Actively Recruiting

Phase 4
Age: 3Years - 18Years
All Genders
Healthy Volunteers
NCT03625011

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

Led by Children's Healthcare of Atlanta · Updated on 2019-07-24

50

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

Who Can Participate

Age: 3Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants age 3 to 18 years
  • ASA class 1 or 2
  • Scheduled for elective tonsillectomy or adenoidectomy
  • Surgery planned as outpatient procedure
Not Eligible

You will not qualify if you...

  • Body mass index greater than 40 kg/m2
  • History of kidney problems or chronic pain
  • Allergy to gabapentin
  • History of developmental delay

AI-Screening

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Trial Site Locations

Total: 1 location

1

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30329

Actively Recruiting

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Research Team

B

Beena Desai

CONTACT

M

Margaret A Gettis, DNP,CPNP-PC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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