Effect of melatonin dosage on sleep disorder in tuberous sclerosis complex
Male; Treatment Outcome; Dose-Response Relationship Drug; Child; Humans; Adult; Cross-Over Studies; Female; Child Preschool; Infant; Administration Oral; Double-Blind Method; Tuberous Sclerosis/complications; Antioxidants/pharmacology/therapeutic use; Melatonin/pharmacology/therapeutic use; Sleep Wake Disorders/drug therapy/etiology; sleep disturbance/disorders; tuberous sclerosis; pharmacologic intervention; melatonin
We report a randomized, double-blind, controlled, crossover trial investigating the response to oral melatonin using two dose regimens in patients with sleep disorders associated with tuberous sclerosis complex. Eight outpatients with tuberous sclerosis complex and sleep disorder received either 5 or 10 mg of melatonin. Sleep latency, total sleep time, number of awakenings, and seizure frequency were recorded in sleep and seizure diaries. No evidence of a dose effect between 5 and 10 mg was seen with respect to any outcome measure. (The 5 mg results are given first: sleep latency, 86 and 76 minutes; total sleep time, 8 hours, 57 minutes and 9 hours, 4 minutes; and sleep fragmentation, 0.8 and 1.0). This study might have missed a small beneficial effect of 10 mg melatonin. We propose that an initial trial of 5 mg melatonin is worth considering in patients with tuberous sclerosis complex and sleep disorder.
Hancock E; O'Callaghan F; Osborne J P
Journal of Child Neurology
2005
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<a href="http://doi.org/10.1177/08830738050200011302" target="_blank" rel="noreferrer noopener">10.1177/08830738050200011302</a>
Mirror therapy for phantom limb pain
Humans; Pain Measurement; Movement; Cross-Over Studies; Amputation Stumps; Amputation/adverse effects; Audiovisual Aids; Biofeedback (Psychology); Imagery (Psychotherapy); Phantom Limb/therapy
2007
Chan BL; Witt R; Charrow AP; Magee A; Howard R; Pasquina PF; Heilman KM; Tsao JW
The New England Journal Of Medicine
2007
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Journal Article
<a href="http://doi.org/10.1056/NEJMc071927" target="_blank" rel="noreferrer">10.1056/NEJMc071927</a>
Smoked cannabis for chronic neuropathic pain: a randomized controlled trial
Female; Humans; Male; Pain Measurement; Adult; Aged; Middle Aged; Treatment Outcome; Linear Models; Double-Blind Method; Cross-Over Studies; quality of life; Chronic disease; Sleep/drug effects; Placebos; Neuralgia/drug therapy; Marijuana Smoking; Tetrahydrocannabinol/administration & dosage/adverse effects/therapeutic use
BACKGROUND: Chronic neuropathic pain affects 1%-2% of the adult population and is often refractory to standard pharmacologic treatment. Patients with chronic pain have reported using smoked cannabis to relieve pain, improve sleep and improve mood. METHODS: Adults with post-traumatic or postsurgical neuropathic pain were randomly assigned to receive cannabis at four potencies (0%, 2.5%, 6% and 9.4% tetrahydrocannabinol) over four 14-day periods in a crossover trial. Participants inhaled a single 25-mg dose through a pipe three times daily for the first five days in each cycle, followed by a nine-day washout period. Daily average pain intensity was measured using an 11-point numeric rating scale. We recorded effects on mood, sleep and quality of life, as well as adverse events. RESULTS: We recruited 23 participants (mean age 45.4 [standard deviation 12.3] years, 12 women [52%]), of whom 21 completed the trial. The average daily pain intensity, measured on the 11-point numeric rating scale, was lower on the prespecified primary contrast of 9.4% v. 0% tetrahydrocannabinol (5.4 v. 6.1, respectively; difference = 0.7, 95% confidence interval [CI] 0.02-1.4). Preparations with intermediate potency yielded intermediate but nonsignificant degrees of relief. Participants receiving 9.4% tetrahydrocannabinol reported improved ability to fall asleep (easier, p = 0.001; faster, p < 0.001; more drowsy, p = 0.003) and improved quality of sleep (less wakefulness, p = 0.01) relative to 0% tetrahydrocannabinol. We found no differences in mood or quality of life. The most common drug-related adverse events during the period when participants received 9.4% tetrahydrocannabinol were headache, dry eyes, burning sensation in areas of neuropathic pain, dizziness, numbness and cough. CONCLUSION: A single inhalation of 25 mg of 9.4% tetrahydrocannabinol herbal cannabis three times daily for five days reduced the intensity of pain, improved sleep and was well tolerated. Further long-term safety and efficacy studies are indicated. (International Standard Randomised Controlled Trial Register no. ISRCTN68314063).
2010
Ware M; Wang T; Shapiro S; Robinson A; Ducruet T; Huynh T; Gamsa A; Bennett GJ; Collet JP
Canadian Medical Association Journal
2010
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Journal Article
<a href="http://doi.org/10.1503/cmaj.091414" target="_blank" rel="noreferrer">10.1503/cmaj.091414</a>
Benefits of an add-on treatment with the synthetic cannabinomimetic nabilone on patients with chronic pain--a randomized controlled trial
Female; Humans; Male; Middle Aged; Treatment Outcome; Anti-Anxiety Agents; Double-Blind Method; Cross-Over Studies; quality of life; Chronic disease; Pain/drug therapy; Pain Measurement/drug effects; Adjuvant; Cannabinoids/administration & dosage; Chemotherapy; Placebo Effect; Tetrahydrocannabinol/administration & dosage/analogs & derivatives
OBJECTIVE: The aim of this study was to investigate the efficacy and efficiency of an add-on treatment with the synthetic cannabinomimetic nabilone on patients with chronic pain. Of major interest were the evaluation of the influence the treatment had on pain and on quality of life as well as the subjective assessment of positive effects and side effects by the study participants. METHODS: The placebo-controlled double-blinded pilot study was divided into a 14 week cross-over period (two 4 week medication phases plus wash-out phases) followed by a 16 week medication switch period with free choice of the study drugs (drug A and drug B) by the study participants. The principal inclusion criterion was chronic therapy-resistant pain in causal relationship with a pathologic status of the skeletal and locomotor system. The study participants chose the dosage of the study drug themselves (between 1 und 4 capsules/day, in the case of nabilone this corresponds to (1/4)-1 mg/day). Pain intensity was assessed by a visual analogue scale (VAS), quality of life by the Mezzich and Cohen QOL-score. RESULTS: Altogether, 30 patients were included and analyzed. From the results, it is obvious that throughout the cross-over periods the nabilone treatment was superior (medians [25%-; 75%-percentiles]: nabilone/placebo): decrease of the average spinal pain intensity within the last 4 weeks (DeltaVAS) 0.9 [0.0; 2.0] / 0.5 [0.0; 1.7], decrease of the current spinal pain intensity (DeltaVAS) 0.6 [0.0; 2.5] / 0.0 [-1.0, 1.0] (p = .006), decrease of the average headache intensity within the last 4 weeks (DeltaVAS) 1.0 [-1.0; 2.4] / 0.2 [-0.9; 1.0], increase of the number of days without headache within the last 4 weeks 2.0 [0.0; 6.5] / 0.0 [-5.0; 4.0], increase of the quality of life (DeltaQOL-Score) 5.0 [0.8; 10.8] / 2.0 [-2.3; 8.0]. In the medication switch period, the number of study participants who favoured nabilone (nabilone intake > or =85% of all medication days) was more than 4 times higher than those who favoured placebo. The number of days with nabilone intake was clearly higher than the number with placebo intake (medians: 89% vs. 11% of all medication days, p = .003). CONCLUSION: In summary, the study results allow the conclusion that a majority of patients with chronic pain classify nabilone intake in addition to the standard treatment as a measure with a positive individual benefit-riskratio. Thus, this kind of treatment may be an interesting and attractive enrichment of analgetic therapy concepts.
2006
Pinsger M; Schimetta W; Volc D; Hiermann E; Riederer F; Polz W
Wiener Klinische Wochenschrift
2006
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Journal Article
<a href="http://doi.org/10.1007/s00508-006-0611-4" target="_blank" rel="noreferrer">10.1007/s00508-006-0611-4</a>
Widespread pain in fibromyalgia is related to a deficit of endogenous pain inhibition
Female; Humans; Male; Adult; Middle Aged; Regression Analysis; Cross-Over Studies; Non-U.S. Gov't; Research Support; Comparative Study; Pain Measurement/methods; Cold/diagnostic use; Fibromyalgia/diagnosis/physiopathology; Neural Inhibition/physiology; Pain/diagnosis/physiopathology
A deficit of endogenous pain inhibitory systems has been suggested to contribute to some chronic pain conditions, one of them being fibromyalgia. The aim of the investigation was to test whether endogenous pain inhibitory systems were activated by a spatial summation procedure in 30 fibromyalgia, 30 chronic low back pain, and 30 healthy volunteers who participated in a cross-over trial (two sessions). Each session consisted of visual analog scale ratings of pain during the immersion of different surfaces of the arm in circulating noxious cold (12 degrees C) water. The arm was arbitrarily divided into eight segments from the fingertips to the shoulder. One session was ascending (from the fingertips to the shoulder) and the other was descending (from the shoulder to the fingertips); they included eight consecutive 2-min immersions separated by 5-min resting periods. For healthy and low back pain subjects, pain was perceived differently during the ascending and descending sessions (P=0.0001). The descending session resulted in lower pain intensity and unpleasantness. This lowering of the perception curve seems to be due to a full recruitment of inhibitory systems at the beginning of the descending session as opposed to a gradual recruitment during the ascending session. For fibromyalgia subjects, no significant differences were found between the increasing and decreasing sessions (P>0.05). These data support a deficit of endogenous pain inhibitory systems in fibromyalgia but not in chronic low back pain. The treatments proposed to fibromyalgia patients should aim at stimulating the activity of those endogenous systems.
2005
Julien N; Goffaux P; Arsenault P; Marchand S
Pain
2005
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Journal Article
<a href="http://doi.org/10.1016/j.pain.2004.12.032" target="_blank" rel="noreferrer">10.1016/j.pain.2004.12.032</a>
Effect of sublingual application of cannabinoids on intraocular pressure: a pilot study
Humans; Male; Middle Aged; Pilot Projects; Double-Blind Method; Cross-Over Studies; Administration; Sublingual; Cannabidiol/administration & dosage; Glaucoma; Intraocular Pressure/drug effects; Ocular Hypertension/drug therapy; Open-Angle/drug therapy; Psychotropic Drugs/administration & dosage; Tetrahydrocannabinol/administration & dosage; Visual Acuity/drug effects
PURPOSE: The purpose of this study was to assess the effect on intraocular pressure (IOP) and the safety and tolerability of oromucosal administration of a low dose of delta-9-tetrahydrocannabinol (Delta-9-THC) and cannabidiol (CBD). PATIENTS AND METHODS: A randomized, double-masked, placebo-controlled, 4 way crossover study was conducted at a single center, using cannabis-based medicinal extract of Delta-9-THC and CBD. Six patients with ocular hypertension or early primary open angle glaucoma received a single sublingual dose at 8 AM of 5 mg Delta-9-THC, 20 mg CBD, 40 mg CBD, or placebo. Main outcome measure was IOP. Secondary outcomes included visual acuity, vital signs, and psychotropic effects. RESULTS: Two hours after sublingual administration of 5 mg Delta-9-THC, the IOP was significantly lower than after placebo (23.5 mm Hg vs. 27.3 mm Hg, P=0.026). The IOP returned to baseline level after the 4-hour IOP measurement. CBD administration did not reduce the IOP at any time. However, the higher dose of CBD (40 mg) produced a transient elevation of IOP at 4 hours after administration, from 23.2 to 25.9 mm Hg (P=0.028). Vital signs and visual acuity were not significantly changed. One patient experienced a transient and mild paniclike reaction after Delta-9-THC administration. CONCLUSIONS: A single 5 mg sublingual dose of Delta-9-THC reduced the IOP temporarily and was well tolerated by most patients. Sublingual administration of 20 mg CBD did not reduce IOP, whereas 40 mg CBD produced a transient increase IOP rise.
2006
Tomida I; Azuara-Blanco A; House H; Flint M; Pertwee RG; Robson PJ
Journal Of Glaucoma
2006
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Journal Article
<a href="http://doi.org/10.1097/01.ijg.0000212260.04488.60" target="_blank" rel="noreferrer">10.1097/01.ijg.0000212260.04488.60</a>
Acupuncture against chemotherapy-induced nausea and vomiting in pediatric oncology. Interim results of a multicenter crossover study
Child; Female; Humans; Male; Prospective Studies; Treatment Outcome; Cross-Over Studies; Drug Administration Schedule; adolescent; Non-U.S. Gov't; Research Support; PedPal Lit; Acupuncture Therapy; Antiemetics/administration & dosage/therapeutic use; Antineoplastic Agents/adverse effects/therapeutic use; Nausea/chemically induced/prevention & control; Vomiting/chemically induced/prevention & control
GOALS: In this multicenter crossover study, our aim was to evaluate the efficacy and acceptance of acupuncture as a supportive antiemetic approach during highly emetogenic chemotherapy in pediatric oncology. PATIENTS AND METHODS: Eleven children receiving several courses of highly emetogenic chemotherapy for treatment of solid tumors were included. Randomization allocated patients to start chemotherapy either with antiemetic medication plus acupuncture or antiemetic medication alone. During all study courses, patients continued to receive their programmed and additional antiemetic medication as needed. Acupuncture was given at day 1 of chemotherapy and at subsequent days on patient's demand. The amount of baseline and additional antiemetic medication during chemotherapy was documented. Patients maintained a daily diary of vomiting episodes and completed an evaluated nausea score at the end of every course. Their body weight was taken before and after a chemotherapy course. MAIN RESULTS: Twenty-two courses with or without acupuncture were compared. The benefits of acupuncture in adolescents with respect to the reduction of additional antiemetic medication were observed. Acupuncture enabled patients to experience higher levels of alertness during chemotherapy and reduced nausea and vomiting. Except for needle pain, no side effects were noted. Patient's acceptance of acupuncture was high. CONCLUSION: Our data indicate that acupuncture might reduce antiemetic medication and episodes of vomiting in pediatric oncology.
2006
Reindl TK; Geilen W; Hartmann R; Wiebelitz KR; Kan G; Wilhelm I; Lugauer S; Behrens C; Weiberlenn T; Hasan C; Gottschling S; Wild-Bergner T; Henze G; Driever PH
Support Care Cancer
2006
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Journal Article
Analgesic effect of the synthetic cannabinoid CT-3 on chronic neuropathic pain: a randomized controlled trial
Female; Humans; Male; Pain Measurement; Adult; Analgesics; Middle Aged; Double-Blind Method; Cross-Over Studies; Non-U.S. Gov't; Research Support; Chronic disease; Hyperalgesia/complications/drug therapy; Non-Narcotic/therapeutic use; Pain/complications/drug therapy; Tetrahydrocannabinol/analogs & derivatives/therapeutic use
CONTEXT: 1',1'dimethylheptyl-Delta8-tetrahydrocannabinol-11-oic acid (CT-3), a potent analog of THC-11-oic acid, produces marked antiallodynic and analgesic effects in animals without evoking the typical effects described in models of cannabinoids. Therefore, CT-3 may be an effective analgesic for poorly controlled resistant neuropathic pain. OBJECTIVE: To examine the analgesic efficacy and safety of CT-3 in chronic neuropathic pain in humans. DESIGN AND SETTING: Randomized, placebo-controlled, double-blind crossover trial conducted in Germany from May-September 2002. PARTICIPANTS: Twenty-one patients (8 women and 13 men) aged 29 to 65 years (mean, 51 years) who had a clinical presentation and examination consistent with chronic neuropathic pain (for at least 6 months) with hyperalgesia (n = 21) and allodynia (n = 7). INTERVENTIONS: Patients were randomized to two 7-day treatment orders in a crossover design. Two daily doses of CT-3 (four 10-mg capsules per day) or identical placebo capsules were given during the first 4 days and 8 capsules per day were given in 2 daily doses in the following 3 days. After a washout and baseline period of 1 week each, patients crossed over to the second 7-day treatment period. MAIN OUTCOME MEASURES: Visual analog scale (VAS) and verbal rating scale scores for pain; vital sign, hematologic and blood chemistry, and electrocardiogram measurements; scores on the Trail-Making Test and the Addiction Research Center Inventory-Marijuana scale; and adverse effects. RESULTS: The mean differences over time for the VAS values in the CT-3-placebo sequence measured 3 hours after intake of study drug differed significantly from those in the placebo-CT-3 sequence (mean [SD], -11.54 [14.16] vs 9.86 [21.43]; P =.02). Eight hours after intake of the drug, the pain scale differences between groups were less marked. No dose response was observed. Adverse effects, mainly transient dry mouth and tiredness, were reported significantly more often during CT-3 treatment (mean [SD] difference, -0.67 [0.50] for CT-3-placebo sequence vs 0.10 [0.74] for placebo-CT-3 sequence; P =.02). There were no significant differences with respect to vital signs, blood tests, electrocardiogram, Trail-Making Test, and Addiction Research Center Inventory-Marijuana scale. No carryover or period effects were observed except on the Trail-Making Test. CONCLUSIONS: In this preliminary study, CT-3 was effective in reducing chronic neuropathic pain compared with placebo. No major adverse effects were observed.
2003
Karst M; Salim K; Burstein S; Conrad I; Hoy L; Schneider U
Jama
2003
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Journal Article
<a href="http://doi.org/10.1001/jama.290.13.1757" target="_blank" rel="noreferrer">10.1001/jama.290.13.1757</a>
Initial experiences with medicinal extracts of cannabis for chronic pain: results from 34 'N of 1' studies
Female; Humans; Male; Adult; Analgesics; Aged; Middle Aged; Treatment Outcome; Patient Selection; Double-Blind Method; Cross-Over Studies; Chronic disease; Administration; Pain/drug therapy; Drug Combinations; Sleep/drug effects; Pain Measurement/methods; Sublingual; Cannabidiol/adverse effects/therapeutic use; Depressive Disorder/drug therapy; Multiple Sclerosis/drug therapy; Non-Narcotic/adverse effects/therapeutic use; Tetrahydrocannabinol/adverse effects/therapeutic use
Three Cannabis Based Medicinal Extracts (CBMEs) for sublingual use became available in 2000. A total of 34 'N of 1' studies were undertaken using this novel therapy for patients with chronic, mainly neuropathic, pain and associated symptoms to explore efficacy, tolerability, safety and dosages. Three CBMEs (Delta9 Tetrahydrocannabinol (THC), Cannabidiol (CBD) and a 1:1 mixture of them both) were given over a 12-week period. After an initial open-label period, the CBMEs were used in a randomised, double-blind, placebo controlled, crossover trial. Extracts which contained THC proved most effective in symptom control. Regimens for the use of the sublingual spray emerged and a wide range of dosing requirements was observed. Side-effects were common, reflecting a learning curve for both patient and study team. These were generally acceptable and little different to those seen when other psycho-active agents are used for chronic pain. These initial experiences with CBME open the way to more detailed and extensive studies.
2004
Notcutt W; Price M; Miller R; Newport S; Phillips C; Simmons S; Sansom C
Anaesthesia
2004
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Journal Article
<a href="http://doi.org/10.1111/j.1365-2044.2004.03674.x" target="_blank" rel="noreferrer">10.1111/j.1365-2044.2004.03674.x</a>
Activation of peripheral NMDA receptors contributes to human pain and rat afferent discharges evoked by injection of glutamate into the masseter muscle
Female; Humans; Male; Adult; Analysis of Variance; Animals; Double-Blind Method; Cross-Over Studies; Rats; Non-U.S. Gov't; Research Support; Nonparametric; Statistics; Dose-Response Relationship; Drug; Receptors; Sprague-Dawley; Afferent Pathways/drug effects/physiology; Glutamic Acid/pharmacology; Masseter Muscle/drug effects/physiology; N-Methyl-D-Aspartate/agonists/antagonists & inhibitors/metabolism; Pain/chemically induced/physiopathology
Peripheral N-methyl-d-aspartate (NMDA) receptors are found in deep tissues and may play a role in deep tissue pain. Injection of the endogenous NMDA receptor agonist glutamate into the masseter muscle excites deep craniofacial afferent fibers in rats and evokes pain in human subjects. It is not clear whether peripheral NMDA receptors play a role in these effects of glutamate. Accordingly, the effect of NMDA on afferent activity as well as the effect of locally administered NMDA receptor antagonists on glutamate-evoked afferent discharges in acutely anesthetized rats and muscle pain in human subjects was examined. Injection of NMDA into the masseter muscle evoked afferent discharges in a concentration-related manner. It was found that the NMDA receptor antagonists 2-amino-5-phosphonvalerate (APV, 10 mM), ketamine (10 mM), and dextromethorphan (40 mM) significantly decreased glutamate-evoked afferent discharges. The effects of APV and ketamine, but not dextromethorphan, were selective for glutamate-evoked afferent discharges and did not affect hypertonic saline-evoked afferent discharges. In human experiments, it was found that 10 mM ketamine decreased glutamate-evoked muscle pain but had no effect on hypertonic saline-evoked muscle pain. These results indicate that injection of glutamate into the masseter muscle evokes afferent discharges in rats and muscle pain in humans in part through activation of peripheral NMDA receptors. It is conceivable that activation of peripheral NMDA receptors may contribute to masticatory muscle pain and that peripherally acting NMDA receptor antagonists could prove to be effective analgesics for this type of pain.
2003
Cairns BE; Svensson P; Wang K; Hupfeld S; Graven-Nielsen T; Sessle BJ; Berde CB; Arendt-Nielsen L
Journal Of Neurophysiology
2003
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Journal Article
<a href="http://doi.org/10.1152/jn.00353.2003" target="_blank" rel="noreferrer">10.1152/jn.00353.2003</a>
Practice parameter: pharmacological treatment of migraine headache in children and adolescents: report of the American Academy of Neurology Quality Standards Subcommittee and the Practice Committee of the Child Neurology Society
Child; Female; Humans; Male; Evidence-Based Medicine; Double-Blind Method; Cross-Over Studies; Forecasting; adolescent; Preschool; retrospective studies; Anti-Inflammatory Agents; Randomized Controlled Trials; Anticonvulsants/therapeutic use; Non-Steroidal/therapeutic use; Antidepressive Agents/therapeutic use; Analgesics/classification/therapeutic use; Antihypertensive Agents/therapeutic use; Calcium Channel Blockers/therapeutic use; Migraine Disorders/drug therapy/prevention & control; Serotonin Agonists/therapeutic use
OBJECTIVE: To review evidence on the pharmacologic treatment of the child with migraine headache. METHODS: The authors reviewed, abstracted, and classified relevant literature. Recommendations were based on a four-tiered scheme of evidence classification. Treatment options were separated into medications for acute headache and preventive medications. RESULTS: The authors identified and reviewed 166 articles. For acute treatment, five agents were reviewed. Sumatriptan nasal spray and ibuprofen are effective and are well tolerated vs placebo. Acetaminophen is probably effective and is well tolerated vs placebo. Rizatriptan and zolmitriptan were safe and well tolerated but were not superior to placebo. For preventive therapy, 12 agents were evaluated. Flunarizine is probably effective. The data concerning cyproheptadine, amitriptyline, divalproex sodium, topiramate, and levetiracetam were insufficient. Conflicting data were found concerning propranolol and trazodone. Pizotifen, nimodipine, and clonidine did not show efficacy. CONCLUSIONS: For children (>age 6 years), ibuprofen is effective and acetaminophen is probably effective and either can be considered for the acute treatment of migraine. For adolescents (>12 years of age), sumatriptan nasal spray is effective and should be considered for the acute treatment of migraine. For preventive therapy, flunarizine is probably effective and can be considered, but is not available in the United States. There are conflicting or insufficient data to make any other recommendations for the preventive therapy of migraine in children and adolescents. For a clinical problem so prevalent in children and adolescents, there is a disappointing lack of evidence from controlled, randomized, and masked trials.
2004
Lewis D; Ashwal S; Hershey A; Hirtz D; Yonker M; Silberstein S; American Academy of Neurology Quality Standards Subcommittee; Practice Committee of the Child Neurology Society
Neurology
2004
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Journal Article
<a href="http://doi.org/10.1212/01.wnl.0000147332.41993.90" target="_blank" rel="noreferrer">10.1212/01.wnl.0000147332.41993.90</a>
Comparative clinical efficacy and safety of a novel controlled-release oxycodone formulation and controlled-release hydromorphone in the treatment of cancer pain
Female; Humans; Analgesics; Middle Aged; Double-Blind Method; Cross-Over Studies; Comparative Study; Neoplasms/complications; Delayed-Action Preparations; Drug Evaluation; Hydromorphone/administration & Male; Opioid/administration & dosage; Oxycodone/administration & Pain/drug therapy
BACKGROUND: The use of oxycodone to treat chronic cancer pain has been hampered by its short elimination half-life, which necessitates administration every 4 hours. This study compared the clinical efficacy and safety of a novel oxycodone formulation with that of hydromorphone in the treatment of cancer pain. METHODS: In a double-blind crossover study, 44 patients with stable cancer pain were randomized to controlled-release oxycodone or controlled-release hydromorphone, each given every 12 hours for 7 days. Pain intensity, nausea, and sedation were assessed by patients four times daily, and breakthrough analgesia was recorded. RESULTS: Thirty-one patients completed the study (18 women, 13 men; mean age, 56 +/- 3 years) and received a final controlled-release oxycodone dose of 124 +/- 22 mg per day and a final controlled-release hydromorphone dose of 30 +/- 6 mg per day. There were no significant differences between treatments in overall Visual Analogue Scale (VAS) pain intensity (VAS 28 +/- 4 mm vs. 31 +/- 4 mm), categorical pain intensity (1.4 +/- 0.1 vs. 1.5 +/- 0.1), daily rescue analgesic consumption (1.4 +/- 0.3 vs. 1.6 +/- 0.3), sedation scores (24 +/- 4 mm vs. 18 +/- 3 mm), nausea scores (15 +/- 3 mm vs. 13 +/- 3 mm), or patient preference. Two patients experienced hallucinations on controlled-release hydromorphone, but none did while receiving controlled-release oxycodone. CONCLUSIONS: Controlled-release oxycodone demonstrated excellent pharmacodynamic characteristics, analgesic efficacy, and safety as compared with controlled-release hydromorphone and represents an important new therapeutic option for cancer pain management.
Hagen NA; Babul N
Cancer
1997
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Journal Article
<a href="http://doi.org/10.1002/(SICI)1097-0142(19970401)79:7%3C1428::AID-CNCR21%3E3.0.CO" target="_blank" rel="noreferrer">10.1002/(SICI)1097-0142(19970401)79:7%3C1428::AID-CNCR21%3E3.0.CO</a>
Patient-controlled analgesia for mucositis pain in children: a three-period crossover study comparing morphine and hydromorphone
Child; Humans; Pain Measurement; Analgesics; Treatment Outcome; Therapeutic Equivalency; Analgesia; Analysis of Variance; Double-Blind Method; Cross-Over Studies; adolescent; Non-U.S. Gov't; Research Support; Comparative Study; Pain/drug therapy/etiology; Inflammation/complications; Patient-Controlled; Hydromorphone/adverse effects/pharmacokinetics/therapeutic use; Morphine/adverse effects/pharmacokinetics/therapeutic use; Mucous Membrane; Opioid/adverse effects/pharmacokinetics/therapeutic use
OBJECTIVES: (1) To test the safety and efficacy of a clinical protocol for administering opioid by using patient-controlled analgesia (PCA) for the management of mucositis pain in children after bone marrow transplantation, (2) to compare the efficacy, side-effect profile, and potency ratio of morphine with those of hydromorphone by using PCA as the method of opioid administration, and (3) to obtain pharmacokinetic data on hydromorphone and morphine in this population of children. METHODS: In this double-blind, three-period crossover study, patients were randomly assigned to receive either morphine (group 1) or hydromorphone (group 2) initially by means of PCA on days 1, 2, and 3 (period 1), to be followed on days 4, 5, and 6 (period 2) with the alternative opioid, followed by the opioid used at the commencement of the study on days 7, 8, and 9 (period 3). A clinical protocol for calculating the PCA commencement opioid dose and subsequent opioid-dose escalation was tested by measures of safety and efficacy. Measures of pain intensity and opioid side effects were made during the three periods. On the last study day (day 10), patients received a continuous infusion of opioid derived from the previous 24-hour PCA opioid requirement, and blood specimens were collected and stored for subsequent opioid analysis. RESULTS: Ten patients were enrolled in this study. Rapid escalation in opioid requirement commonly occurred at the commencement of PCA, followed by a variable plateau phase and then deescalation of opioid requirement after mucositis resolution. The measures demonstrated the safety and efficacy of the clinical protocol. In the concentrations used, there was no statistical difference between the mean daily pain, sedation, nausea and vomiting, and pruritus scores for both opioids (Friedman test). The analysis of variance of the log-total opioid doses per patient during periods 1, 2, and 3 indicated that patients used 27% more hydromorphone than expected from its presumed 7:1 ratio relative to morphine potency used in the PCA infusions. The mean plasma hydromorphone concentration was 4.7 ng/ml (range, 1.9 to 8.9 ng/ml), and the mean clearance was 51.7 ml/min per kilogram of body weight (range, 28.6 to 98.2 ml/min per kilogram). The mean plasma morphine, morphine-6-glucuronide, and morphine-3-glucuronide concentrations were 40.0 ng/ml (range, 15 to 62.5), 168.2 ng/ml (range, 54.4 to 231.9), and 391.0 ng/ml (range, 149.4 to 921.7), respectively. The mean morphine clearance was 34.3 ml/min per kilogram of body weight (range, 19.3 to 58.3). The mean molar ratios of morphine-6-glucuronide/morphine, morphine-3-glucoronide/morphine, and morphine-3-glucuronide/morphine-6-glucuronide were 2.48 (range, 1.4 to 3.3), 5.82 (range, 3.4 to 9.1), and 2.46 (range, 1.1 to 3.3), respectively. CONCLUSIONS: The safety and efficacy of a clinical protocol for the administration of opioids by means of PCA for mucositis pain after bone marrow transplantation was demonstrated. In this small study, hydromorphone was not superior to morphine in terms of analgesia or the side-effect profile: a larger study would be needed to show a difference. The clearances of hydromorphone and morphine in the children studied were generally greater than those previously recorded, but this finding may be related to disease or treatment variables. Apart from clearance, the morphine pharmacokinetics in the study population were similar to those previously recorded. Hydromorphone may be less potent in this population of children than indicated by adult equipotency tables.
1996
Collins J J; Geake J; Grier HE; Houck CS; Thaler HT; Weinstein HJ; Twum-Danso NY; Berde CB
The Journal Of Pediatrics
1996
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Journal Article
<a href="http://doi.org/10.1016/s0022-3476(96)70156-7" target="_blank" rel="noreferrer">10.1016/s0022-3476(96)70156-7</a>
A randomized, controlled trial of intravenous clodronate in patients with metastatic bone disease and pain
Female; Humans; Male; Pain; Adult; Analgesics; Aged; Middle Aged; Treatment Outcome; Analysis of Variance; Chi-Square Distribution; Cross-Over Studies; 80 and over; Comparative Study; Injections; Intravenous; Dose-Response Relationship; Drug; Clodronate; Pain Measurement/drug effects; Clodronic Acid/administration & dosage; Non-Narcotic/administration & dosage; Intractable/drug therapy/etiology; Bone Neoplasms/complications/secondary
To evaluate the effectiveness of intravenous clodronate in ameliorating refractory bone pain in patients with metastatic bone disease, 60 patients with established osseous metastases and persistent bone pain were randomized to receive either clodronate (600 mg or 1500 mg in 500 mL of normal saline) or 500 mL of saline as placebo. After 2 weeks, the patients were crossed over to receive the alternate treatment. After another 2 weeks, each patient and investigator made a blinded choice. Daily visual analogue scales (VAS) and analgesic diaries were recorded throughout the study period. Forty-six patients were evaluable (77%). A treatment x period interaction was identified in the VAS and daily morphine equivalent dose (DMED) scores. First period analysis of the VAS scores for general pain, pain at rest, and pain upon movement demonstrated an average reduction of 13, 14, and 24 mm, respectively, from baseline, but were not significantly different from changes following placebo. The average change in DMED was -6.4 (SE = 2.9) following clodronate and was +24.6 (SE = 14.9) following placebo (p = 0.03). In the blinded choice of which agent resulted in improvement in pain, 26 (57%) patients chose clodronate, 12 (26%) chose placebo, and eight (17%) had no preference (p = 0.0021). For the investigators who also made a blinded selection, clodronate was chosen in 30 (65%) patients, placebo in ten (22%) patients, and no difference was apparent in six (13%) (p < 0.0001). Intravenous clodronate appeared to have analgesic effect in patients with refractory bone pain due to metastatic bone disease. The optimal dose and duration of effect require further evaluation, particularly in patients with stable disease and persistent bone pain.
1997
Ernst DS; Brasher P; Hagen N; Paterson AH; MacDonald RN; Bruera E
Journal Of Pain And Symptom Management
1997
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Journal Article
<a href="http://doi.org/10.1016/s0885-3924(97)00075-4" target="_blank" rel="noreferrer">10.1016/s0885-3924(97)00075-4</a>
Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment
Humans; Outcome Assessment (Health Care); Research Design; Antidepressive Agents; Cross-Over Studies; Models; Statistical; Chronic disease; Amitriptyline/therapeutic use; Bayes Theorem; Fibromyalgia/drug therapy; Randomized Controlled Trials as Topic/statistics & numerical data; Tricyclic
When treating individual patients, physicians may face difficulties using the evidence from center-based randomized control trials (RCTs) due to limitations in these studies generalizability. Therefore, they often perform their own "informal" tests of treatment effectiveness. Single patient ("N-of-1") trials provide a structured design for more rigorous assessment of medical treatments of chronic diseases, but are applied only to the index patient. We present a hierarchical Bayesian random effects model to combine N-of-1 studies to obtain an estimate of treatment effectiveness for the population and to use this population information to aid in the evaluation of an individual patient's trial results. The model's treatment effect estimates are adjustments between the population estimate and the individual's observed results. This adjustment is based upon the within-patient and between-patient heterogeneity. We demonstrate this patient-focused method using published data from 23 N-of-1 trial results comparing amitriptyline and placebo for the treatment of fibromyalgia.
1997
Zucker DR; Schmid CH; McIntosh MW; D'Agostino RB; Selker HP; Lau J
Journal Of Clinical Epidemiology
1997
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Journal Article
<a href="http://doi.org/10.1016/s0895-4356(96)00429-5" target="_blank" rel="noreferrer">10.1016/s0895-4356(96)00429-5</a>
What do plasma beta-endorphin levels reveal about endogenous opioid analgesic function?
Female; Humans; Male; Adult; Middle Aged; Double-Blind Method; Cross-Over Studies; beta-Endorphin/blood; Biomarkers of Pain; Acute Pain/blood/physiopathology; Analgesia/methods; Chronic Pain/blood/physiopathology; Low Back Pain/blood/physiopathology; Naloxone/pharmacology; Narcotic Antagonists/pharmacology; Pain Measurement/drug effects; Pain Threshold/drug effects/physiology; Physical Stimulation
Bruehl S; Burns JW; Chung OY; Chont M
European Journal Of Pain
2012
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Journal Article
<a href="http://doi.org/10.1002/j.1532-2149.2011.00021.x" target="_blank" rel="noreferrer">10.1002/j.1532-2149.2011.00021.x</a>