RECRUITING

Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-07-31
Study Completion:2019-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03625011

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.

Ages Eligible for Study:3 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * participants age 3-18 years
  2. * ASA class 1 or 2
  3. * elective Tonsillectomy/Adenoidectomy
  4. * outpatient setting.
  1. * BMI \>40kg/m2
  2. * history of renal insufficiency, chronic pain
  3. * allergy to gabapentin
  4. * history of developmental delay

Contacts and Locations

Study Contact

Beena Desai
CONTACT
404-785-2269
beena.desai@choa.org
Margaret A Gettis, DNP,CPNP-PC
CONTACT
404-785-8622
margaret.gettis@choa.org

Principal Investigator

Christina Calamaro, PhD, CPNP-PC
STUDY_CHAIR
Institutional Review Board

Study Locations (Sites)

Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Children's Healthcare of Atlanta

  • Christina Calamaro, PhD, CPNP-PC, STUDY_CHAIR, Institutional Review Board

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 Registration Dates

Study Start Date2018-07-31
Study Completion Date2019-12-31

Study Record Updates

Study Start Date2018-07-31
Study Completion Date2019-12-31

Terms related to this study

Keywords Provided by Researchers

  • Pain Relief
  • Non-Narcotic Pain relief

Additional Relevant MeSH Terms

  • Tonsillitis
  • Tonsillectomy