Gabapentin Premedication for ACL Reconstruction: RCT



Status:Recruiting
Healthy:No
Age Range:12 - 18
Updated:7/25/2018
Start Date:October 9, 2015
End Date:September 1, 2018
Contact:Margaret A Gettis, DNP
Email:margaret.gettis@choa.org
Phone:404-785-8622

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Gabapentin Premedication for Pediatric Anterior Cruciate Ligament Reconstruction: Randomized Control Trial

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 participants interviews with a phone nurse for five days
postoperatively to determine severity of pain as well as use of opioids.

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.

Inclusion Criteria:

- ASA classification 1 or 2

- Scheduled for elective ACL surgery in pediatric outpatient setting

Exclusion Criteria:

- BMI greater than 40

- ASA classification greater than 2

- Recurrent ACL reconstruction

- Allograft ACL reconstruction

- History of renal insufficiency

- History of chronic pain

- Allergy to Gabapentin
We found this trial at
1
site
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Phone: 404-785-2008
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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