Analgesic Effects of Gabapentin After Scoliosis Surgery in Children

NCT00684112 | Completed Phase 3

• 1 other identifier: 1000010379
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to determine whether the use of gabapentin will improve postoperative analgesia and reduce opioid consumption and side effects in children undergoing corrective spinal surgery for idiopathic scoliosis. Secondary aims are to evaluate whether use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases persisting pain and improves patient satisfaction.

Conditions

Scoliosis

Keywords

pediatrics; Scoliosis; Gabapentin

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption postoperatively.

  0 to 24 hours postoperatively

Secondary Outcomes (4)

• Time to first rescue analgesia.

  Determined by outcome

• Pain intensity scores at rest and with movement

  Assessed at 1 hour, 4 hours, 12 hours, 24 hours, 72 hours, and 1 week postoperatively and at the 6-week outpatient follow up visit.

• Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, and presence of persisting pain symptoms

  Assessed at 1 hour, 4 hours, 12 hours, 24 hours, and 48 hours postoperatively.

• Time to first postoperative oral intake as a measure of bowel function.

  Determined by outcome

Study Arms (2)

Gabapentin

EXPERIMENTAL

Single dose preoperative gabapentin

Drug: Gabapentin

Placebo Control

PLACEBO COMPARATOR

Single dose preoperative placebo control

Drug: Placebo

Interventions

Gabapentin DRUG

Patients in this arm of the study will receive two identical capsules, containing 300 mg of oral gabapentin each, 1 hour before surgery.

Gabapentin

Placebo DRUG

Patients in this arm of the study will receive two identical placebo capsules 1 hour before surgery.

Placebo Control

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age
• scheduled for elective surgical correction of scoliosis
• able to operate a patient-controlled analgesia (PCA) pump

You may not qualify if:

• unable to cooperate
• unable to operate the PCA pump
• unable to rate pain
• have a known allergy or sensitivity to gabapentin or morphine
• have a history of chronic pain or daily analgesic use
• have taken acetaminophen, a non-steroidal anti-inflammatory drug, or an antacid within a 24-hour period prior to surgery

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

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

• Arie Peliowski, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

CA (1)