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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01977937
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Pedigo, Oregon Health and Science University

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. 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 opioid medication required for pain control in pediatric post-operative posterior spinal fusion patients.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Gabapentin 250mg/5mL NDC:59762-5025-01 Drug: Simple Syrup Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin on Post-operative Opioid Use and Patient Satisfaction
Study Start Date : November 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gabapentin
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
Placebo Comparator: Simple Syrup
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



Primary Outcome Measures :
  1. Difference in Pain Control When Adding Gabapentin to a Multimodal Pain Management Protocol in Pediatric Post-operative Posterior Spinal Fusion Patients. [ Time Frame: five days ]
    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.


Secondary Outcome Measures :
  1. Opiate Usage in the Gabapentin Group Versus Control. [ Time Frame: Five Days ]
    Total the amount of Hydromorphone and Oxycodone used in milligrams per kilogram in each patient post-operatively, convert this amount to morphine equivalents, and determine if there is a significant difference between the Gabapentin versus Placebo group.



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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977937


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Matthew Halsey, MD Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Elizabeth Pedigo, Oregon Health and Science University:
Informed Consent Form  [PDF] August 29, 2017


Publications of Results:
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Responsible Party: Elizabeth Pedigo, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01977937    
Other Study ID Numbers: IRB00009681
First Posted: November 7, 2013    Key Record Dates
Results First Posted: June 12, 2019
Last Update Posted: June 12, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Elizabeth Pedigo, Oregon Health and Science University:
gabapentin
Analgesic Drugs
Analgesics, Nonopioid
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents