Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin

NCT01977937 | Completed Phase 4 Results DMC

• 1 other identifier: IRB00009681
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the patient experience when using gabapentin with other pain control medications after posterior spinal fusion surgery for scoliosis in adolescents. These results will be compared to patients who underwent the same procedure during the study period and received the same standardized pain control regimen excluding gabapentin. Effects on pain level, opioid use, and satisfaction will be measured. Opioid side effects including nausea, sedation and urinary retention (inability to empty one's bladder) will also be recorded.The null hypotheses are as follows:

1. 1.There is no significant difference in pain control when adding gabapentin to a multimodal pain management protocol in pediatric post-operative posterior spinal fusion patients.
2. 2.There is no significant difference in the amount of opioid medication required for pain control in pediatric post-operative posterior spinal fusion patients.

Conditions

Pain, Postoperative

Keywords

gabapentin; Analgesic Drugs; Analgesics, Nonopioid

Outcome Measures

Primary Outcomes (1)

• Difference in Pain Control When Adding Gabapentin to a Multimodal Pain Management Protocol in Pediatric Post-operative Posterior Spinal Fusion Patients.

  Patients will rate their pain using the Visual Analog Pain Scale (VAS). The VAS is a 10 cm line with anchors of "no pain" and "worst pain imaginable." Patients rate their pain by marking on the 10 cm line where they feel their pain is at the time. The mark is then measured according to where it is along the 10 cm line and reported (range is 0.0 at the "no pain end on the left up to 10.0 at the "worst pain imaginable" on the right). Lower pain scores on the VAS scale are considered a better outcome. The numbers seen in the outcome measure data table below represent an average of the total postoperative VAS scores recorded for each patient from each arm for the duration of their hospital stay.

  five days

Secondary Outcomes (1)

• Opiate Usage in the Gabapentin Group Versus Control.

  Five Days

Study Arms (2)

Gabapentin

EXPERIMENTAL

Gabapentin 15 milligrams per kilogram will be given orally one time pre-operatively. Gabapentin will be continued at a dose of 10 milligrams per kilogram every eight hours orally starting as soon as the patient is admitted to his or her floor bed in the hospital.

Drug: Gabapentin 250mg/5mL NDC:59762-5025-01

Simple Syrup

PLACEBO COMPARATOR

Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital.

Drug: Simple Syrup

Interventions

Gabapentin 250mg/5mL NDC:59762-5025-01 DRUG

Gabapentin

Simple Syrup DRUG

Simple Syrup

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients of age 10-19 with an American Society of Anesthesiologists patient classification of I to III undergoing surgery to correct idiopathic or neurogenic scoliosis.

You may not qualify if:

• Patients who require a surgical approach or technique differing from posterior spinal fusion and/or have allergies to any of the standardized or experimental study medications: acetaminophen, gabapentin, hydromorphone, ketorolac or oxycodone.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.

  PMID: 20418301 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

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

Results Point of Contact

• Title: Dr Elizabeth Pedigo
• Organization: OHSU

pedigo@ohsu.edu

5039705211

Study Officials

• Matthew Halsey, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 12, 2019
• Results First Posted: June 12, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)