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

Pain, Postoperative research study

What is the primary objective of this study?

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, satisfaction and narcotic use after discharge from the hospital 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. 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. There is no significant difference in the amount of opiate medication required for pain control in pediatric post-operative posterior spinal fusion patients.

Who is eligible to participate?

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain, Postoperative

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Gabapentin

Drug:Simple Syrup

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

GabapentinGabapentin 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.

Simple SyrupSimple 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.

Study Status

Recruiting

Start Date: November 2013

Completed Date: September 29, 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Difference in pain control when adding gabapentin to a multimodal pain management protocol in pediatric post-operative posterior spinal fusion patients.

Secondary Outcome: Determine if opiate usage is less in the gabapentin group versus control.

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Oregon Health and Science University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01977937

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.

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