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

Who is this study for? Pediatric patients undergoing tonsillectomy/adenoidectomy
What treatments are being studied? Gabapentin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: t
View:

• participants age 3-18 years

• ASA class 1 or 2

• elective Tonsillectomy/Adenoidectomy

• outpatient setting.

Locations
United States
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Contact Information
Primary
Beena Desai
beena.desai@choa.org
404-785-2269
Backup
Margaret A Gettis, DNP,CPNP-PC
margaret.gettis@choa.org
404-785-8622
Time Frame
Start Date: 2018-07-31
Estimated Completion Date: 2019-12-31
Participants
Target number of participants: 50
Treatments
Placebo_comparator: Placebo Group
Participants will be randomized to either Control Group or Gabapentin Group
Active_comparator: Gabapentin Group
Participants will be randomized to either Control Group or Gabapentin Group
Related Therapeutic Areas
Sponsors
Leads: Children's Healthcare of Atlanta

This content was sourced from clinicaltrials.gov