A randomized trial of amitriptyline and gabapentin are both effective for neuropathic pain in children
Bibliographic record
Abstract
Introduction and AimsTreatment of neuropathic pain and complex regional pain syndrome requires a multimodal approach of pharmacologic, physical, and psychological therapies. While amitriptyline and gabapentin are our front line drugs for treating neuropathic pain, no studies have yet compared them directly to determine which drug might be better for relieving pain, disability and sleep disturbances.ObjectivesOur primary study objective was to compare the efficacy of gabapentin and amitriptyline for treating neuropathic pain in children in a randomized controlled trial (RCT). Secondary objectives were to evaluate changes in childrenu2019s disability and sleep.MethodsEligible participants ranged from 8 to 17 years of age. Diagnosis of neuropathic pain (pre 2011 NP classification) was made at The Hospital for Sick Childrenu2019s Chronic Pain Clinic. Electrocardiograms were performed on all patients prior to study to rule out conduction abnormalities. Patients were prescribed a regimen of pharmacologic, physical, and psychological therapy. Patients received either gabapentin (300 mg tid) or amitriptyline (10 mg qhs) with capsules matched for size and dosing regimen matched with appropriate placebos for a 6-week, triple-blind (patient, physician, data analyst) RCT. Patients completed weekly interviews to obtain outcomes and attended an in-hospital interview at 6 weeks. Primary outcome was a change in usual (i.e., past week) pain intensity from baseline to 6-weeks as measured by an 11-point Colored Analog Scale. Results Thirty-four patients (82% female) were randomized to amitriptyline or gabapentin. Two patients allocated to the amitriptyline group were ineligible due to a contraindicated condition identified at start of trial. Three participants were discontinued from gabapentin and amitriptyline groups (2 and 1, respectively) due to adverse events deemed unrelated to study medications. The primary analysis was based on 29 patients having completed the study. Mean pain intensity at baseline was comparable for 2 groups: 6.5u00b11.4 for amitriptyline and 5.0u00b13.1 for gabapentin. At the end of the 6-week trial, mean usual pain intensity was 5.0u00b13.1 for amitriptyline (a difference of -1.5 from baseline) and 3.3u00b12.3 for gabapentin (a difference of -1.7 from baseline). Usual pain scores did not differ significantly between groups (p > .05, independent sample t-tests). We also found no statistically significant difference between the two drugs in sleep score, suggesting that both drugs impact sleep score to the same degree. Discussion and Conclusion Based on our data, our standard dose of amitriptyline and gabapentin are effective in reducing usual pain intensity ratings in a 6 week trial for children and adolescents with neuropathic pain.Funding u2013Canadian Institutes of Health Research New Emerging Team Grant (GHL - 63209)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.007 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.017 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".