Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Double-Blind, Randomized Clinical Effectiveness Study.
概览
- 阶段
- 3 期
- 干预措施
- Gabapentin
- 疾病 / 适应症
- Pediatric Chronic Neuropathic Pain
- 发起方
- Boston Children's Hospital
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- As a primary outcome, success will be defined by clinically and statistically significant within subject reductions in pain scores
- 状态
- 尚未招募
- 最后更新
- 上个月
概览
简要总结
Given the widespread use of anticonvulsants in the pediatric chronic pain population and the absence of scientific data supporting their use, the investigators propose a randomized, double blind, two group parallel design in which a broad group of children and adolescents with chronic neuropathic pain would be randomized to receive either Gabapentin or Oxcarbazepine.
The Primary Aim of the Study is to assess the frequencies of successful treatment of pediatric patients with neuropathic pain treated with either Gabapentin or Oxcarbazepine.
The Primary Hypotheses are as follows:
Hypothesis I: Both Gabapentin and Oxcarbazepine will result in significant reduction in pain scores when compared to each patient's baseline.
Hypothesis II: Patients who continue on active drug (Gabapentin or Oxcarbazepine) during the second phase of the trial will report greater pain reduction relative to baseline than patients who are randomized onto placebo at this randomization point.
Secondary Aims of the Study are to compare groups treated initially with Gabapentin or Oxcarbazepine with regard to reduction in pain scores (both at rest and with evoked maneuvers), functional disability scores, tolerability, and measures of mood and cognitive functioning.
Secondary Hypotheses are that Gabapentin and Oxcarbazepine differ in their effects on:
- Pain scores at rest and with evoked maneuvers
- Functional disability scores
- Tolerability (frequencies of side-effects)
- Depression and anxiety scales
- Neuropsychological measures of cognitive processing speed, working memory, and attention.
研究者
Monique Ribeiro
Physician
Boston Children's Hospital
入排标准
入选标准
- •Patients between the ages of 8 and 18 at the time of the study with history of chronic (lasting ≥ 4 weeks) neuropathic pain that includes a known injury to a peripheral nerve and/or a pattern of pain responses that includes allodynia, burning, paresthesias or dysesthesias will be included in this study, provided that informed consent has been given by parents.
- •Patient's whose pain rates between moderate to severe at the time of inclusion (ranging from 4-10 in a numeric pain rating scale)
- •Eligible diagnoses include Complex Regional Pain Syndrome, Fibromyalgia, Lumbar Radiculopathy, Spinal Cord Injury, Erythromelalgia, Small Fiber Neuropathies, Traumatic or Post-surgical Peripheral Nerve or Plexus Injuries, and Extremity Pain with severe pain to light touch (allodynia).
- •Child has age-appropriate spoken and written knowledge of English.
- •Parent may be able to utilize an interpreter if need be.
排除标准
- •Unstable psychiatric illness (suicidal ideation, disorganized behavior)
- •Uncontrolled Seizure disorder
- •Chronic Headaches only
- •Abdominal Pain only
- •Prior experience with anticonvulsants for pain treatment.
- •Patients with Syndrome of Inappropriate Secretion of Antidiuretic Hormone
研究组 & 干预措施
Gabapentin
干预措施: Gabapentin
Gabapentin
干预措施: Placebo
Oxcarbazepine
干预措施: Oxcarbazepine
Oxcarbazepine
干预措施: Placebo
Placebo
Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.
干预措施: Gabapentin
Placebo
Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.
干预措施: Oxcarbazepine
Placebo
Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.
干预措施: Placebo
结局指标
主要结局
As a primary outcome, success will be defined by clinically and statistically significant within subject reductions in pain scores
时间窗: 0 (baseline), 2, 4, 6, 8 weeks (post-assignment of intervention)
1. 2 point reduction in average daily pain scores 2. 30% reduction relative to baseline 3. Global overall impression of strong benefit.
次要结局
- Pain Scores at rest and evoked maneuvers(0 (baseline) and 4 and 8 weeks (post assignment of intervention))
- Frequency of side effects- Tolerability(1, 2, 4, 6, 8 weeks (post assignment of intervention))
- Functional Disability Scores(0 (baseline), 4, and 8 weeks (post-assignment of intervention))
- Frequency of Side effects- Depression and Anxiety(Baseline, Week 4 and 8 (post assignment of the intervention))
- Frequency of Side Effects- Neuropsychological Measures(Baseline, weeks 4 and 8 (post-assignment of the intervention).)