Using gabapentin to reduce pain after tonsil surgery in children
Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: Randomized Control Trial
This study is testing if giving gabapentin before tonsil surgery can help reduce pain and the need for stronger pain medications in children aged 3-18.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Healthcare of Atlanta Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT03625011 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of gabapentin in alleviating postoperative pain in children aged 3-18 undergoing tonsillectomy. It is a double-blinded, randomized control trial involving 50 participants who will receive either gabapentin or a placebo before surgery. The study aims to measure pain levels, the amount of narcotics used, and the time to first analgesic post-surgery over a 48-hour period. The hypothesis is that gabapentin will lead to lower narcotic use and reduced pain scores compared to the placebo group.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-18 years undergoing elective tonsillectomy or adenoidectomy with ASA class 1 or 2.
Not a fit: Patients with a BMI over 40 kg/m2, renal insufficiency, chronic pain, or allergies to gabapentin may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for narcotics in pediatric tonsillectomy patients, leading to safer postoperative pain management.
How similar studies have performed: Previous studies have shown promising results with gabapentin for postoperative pain management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * participants age 3-18 years * ASA class 1 or 2 * elective Tonsillectomy/Adenoidectomy * outpatient setting. Exclusion Criteria: * BMI \>40kg/m2 * history of renal insufficiency, chronic pain * allergy to gabapentin * history of developmental delay
Where this trial is running
Atlanta, Georgia
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: Beena Desai
- Email: beena.desai@choa.org
- Phone: 404-785-2269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.