Gabapentin Premedication for ACL Reconstruction: RCT

NCT03417479 | Completed

• 1 other identifier: CHOA IRB 15-094
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction

Outcome Measures

Primary Outcomes (1)

• Effective Dose determination

  To determine whether one 15mg/kg (up to 600 mg) dose of gabapentin preoperatively reduces pain after ACL surgery over the first 5 days of the postoperative period

  5 days post surgery

Study Arms (1)

1:1 Randomization

Patients will be randomized to either a single dose of 15mg/kg up to 600 mg of gabapentin or a placebo equivalent at a 1:1 ratio. The subjects will be enrolled in the study at the orthopedic surgeon's office with randomization occurring on the day of surgery by the hospital pharmacist. The method for the randomization will be the creation of a sequence of sealed envelopes containing assignment information for a dose of 600 mg of gabapentin or placebo.

Other: Gabapentin

Interventions

Gabapentin OTHER

Also known as: Neurontin

1:1 Randomization

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Inclusion criteria include patients ages 12-18 years with an ASA class 1 or 2 scheduled for elective ACL reconstruction in the outpatient setting by Dr. Michael Busch. Exclusion criteria include a BMI \>40, recurrent ACL reconstruction, allograft ACL reconstruction, history of renal insufficiency, chronic pain or allergy to gabapentin.

You may qualify if:

• ASA classification 1 or 2
• Scheduled for elective ACL surgery in pediatric outpatient setting

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30043, United States

Location

Related Publications (1)

• Gettis M, Brown AM, Fujimoto A, Wetzel M, Thomsen J. Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: A Pilot Study. J Perianesth Nurs. 2022 Oct;37(5):626-631. doi: 10.1016/j.jopan.2021.11.011. Epub 2022 Mar 5.

  PMID: 35256248 DERIVED

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Margaret A Gettis, DNP

  Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: January 31, 2018
• Study Start: October 9, 2015
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: December 8, 2021

Record last verified: 2019-07

Locations

US (1)