Gabapentin Premedication for Pediatric Anterior Cruciate Ligament Reconstruction: Randomized Control Trial
Data Collection
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 9, 2015
Actual date on which the first participant was enrolled.Anterior Cruciate Ligament (ACL) injury and surgical repair occurs in 200,000 active adolescent and young adult patients each year. ACL repair is associated with significant postoperative pain. Current methodologies for pain include regional nerve blocks, opioid or non-steroidal analgesia. Few studies have evaluated use of neuro-inhibitors such as gabapentin to limit pain response. The purpose of this study then is to examine the use of gabapentin in reducing postoperative pain in adolescent ACL patients. The investigators hypothesize one 15mg/kg (up to 600mg) dose of gabapentin preoperatively would reduce: 1) self-reported postoperative pain and, 2) opioid use compared to patients who do not receive preoperative gabapentin. This double blind randomized control trial will enroll 100 participants ages 12-18 years, undergoing ACL repair. Participants receive gabapentin or placebo preoperatively. Outcome measurements of self-reported pain score using scale of 1 to 10 with 10 being the worse obtained from the EMR and participant interviews with a phone nurse for five days postoperatively to determine severity of pain as well as use of opioids. Outcome measurements will give a more comprehensive description of the postoperative experience and test gabapentin's opioid sparing effect. Due to paucity of literature on pain relief in this population, this pilot study will inform a larger multi-site study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.57 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Children's Healthcare of Atlanta
Atlanta, United StatesOpen Children's Healthcare of Atlanta in Google Maps