Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

July 23, 2019 updated by: Margaret Gettis, Children's Healthcare of Atlanta

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: Randomized Control 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As from a regional healthcare organization. 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. Additionally, young children will receive instruction for Tylenol and Motrin postoperatively while teenagers will receive a narcotic prescription. Outcome measurements include: mean Tylenol mg/kg, Motrin mg/kg and narcotic mg/kg use. Additional measurements: Mean time to first analgesic. Phone interviews with the research nurse for three days postoperatively will elicit pain scores at 12, 24 and 48 hours postoperatively.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Group
Participants will be randomized to either Control Group or Gabapentin Group
Drug: Gabapentin
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.
Other Names:
  • Neurontin
ACTIVE_COMPARATOR: Gabapentin Group
Participants will be randomized to either Control Group or Gabapentin Group
Drug: Gabapentin
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.
Other Names:
  • Neurontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic Consumption
Time Frame: First 48 hours postoperatively
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).
First 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Analgesic Timing
Time Frame: First 48 Hours postoperatively
To record the time to first analgesic postoperatively
First 48 Hours postoperatively
Pain Scale Scores
Time Frame: 12, 24 and 48 hours postoperatively.
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.
12, 24 and 48 hours postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Healthcare of Atlanta

Investigators

  • Study Chair: Christina Calamaro, PhD, CPNP-PC, Institutional Review Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 31, 2018

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (ACTUAL)

August 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 18-052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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