N/A N=36 Randomized Quadruple-blind Treatment

Preoperative Gabapentin for Post-tonsillectomy Pain in Children

Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy

Bottom Line

View on ClinicalTrials.gov: NCT01707420 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Total Oral Analgesia Consumption — 0.228; 0.224; 0.200; 0.193 cumulative hydrocodone (mg/kg)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Gabapentin (Drug); liquid placebo (Drug)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Oral Analgesia Consumption	0.228; 0.224; 0.200; 0.193; 0.171; 0.165	—
SECONDARY Self-report Pain Score at Rest	5.33; 5.08; 4.33; 5.80; 4.00; 3.60	—
SECONDARY Self-report Pain Score When Swallowing	6.47; 5.42; 4.78; 6.00; 5.40; 5.50	—

Summary

The typical post-operative course for children following surgical removal of their tonsils and adenoids can be challenging, especially for pain control. First line medications for pain include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be short-lived. Gabapentin has been shown in adult studies to tone down the body's response to pain and decreases opioid use post-operatively. The purpose of this study is to see if a single preoperative dose will reduce post-operative pain scores and the amount of analgesic used.

Eligibility Criteria

Inclusion Criteria

scheduled for outpatient tonsillectomy and adenoidectomy
< 60 Kg, between 5th and 95th percentile for weight
ability to self-report pain
complete pain diary with assistance from parent or guardian

Exclusion Criteria

require pre-anesthesia medication for anxiety
require interpreter for verbal or written communication
Obstructive sleep apnea significant enough to not qualify for outpatient surgery per surgeon
ongoing oxygen dependence, pulmonary hypertension
elevated risk of regurgitation
history of seizures
currently taking psychoactive medications or having a psychiatric condition requiring medications
chronic pain disorders requiring medications
renal disease
developmental or cognitive disabilities
history of adverse reactions to components of liquid gabapentin or placebo

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01707420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.