Health TrialsbyHealthPanel

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

ConditionsTonsillitisTonsillectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-18
SponsorChildren's Healthcare of Atlanta

About this trial

The purpose of this pilot study: 1) to examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg given 2) to record the time to first analgesic postoperatively and 3) to compare Wong Baker and the 0-10 numeric pain distress scale scores at 12, 24 and 48 hours postoperatively. We hypothesize one 15mg/kg (up to 600mg) dose of gabapentin will decrease mean narcotic amounts in mg/kg compared to participants who do not receive preoperative gabapentin and will demonstrate a decreased mean time to first analgesic as well as to lower mean pain scores for each age group at 12, 24 and 48 hours.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

participants age 3-18 years

ASA class 1 or 2

elective Tonsillectomy/Adenoidectomy

outpatient setting.

Disqualifiers

BMI >40kg/m2

history of renal insufficiency, chronic pain

allergy to gabapentin

history of developmental delay

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gabapentin

    Drug

    This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Placebo GroupPlacebo comparator 1 intervention
Group B: Gabapentin GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Narcotic Consumption

To examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg(weight and height will be combined to report BMI in kg/m\^2).

Time frame
First 48 hours postoperatively

Secondary outcomes

1

First Analgesic Timing

To record the time to first analgesic postoperatively

Time frame
First 48 Hours postoperatively
2

Pain Scale Scores

To compare the Wong- Baker FACES Pain Rating Scale and the 1-10 numeric pain distress scale pain scores at 12, 24 and 48 hours postoperatively. The 0-10 Numeric Pain Distress Pain Scale utilizes number gradations to describe pain for school age children and adolescents. A zero score means the absence of pain while a five describes distressing pain and a ten infers unbearable pain. As for the Wong-Baker FACES Scale, a series of faces can be shown to children over the age of three. The six faces depict facial expressions with zero-no hurt at all, one-hurts just a little bit, two-hurts a little more, three-hurts even more, four-hurts a whole lot, and five- hurts as much as you can imagine. No subscales will be used or combined.

Time frame
12, 24 and 48 hours postoperatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Healthcare of Atlanta

Lead sponsor

Source ClinicalTrials.gov
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