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The Effect of Neurontin on Pain Management in the Acutely Burned Patient

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ClinicalTrials.gov Identifier: NCT01265056
Recruitment Status : Completed
First Posted : December 22, 2010
Results First Posted : February 26, 2013
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Burn patients have extreme pain. Opioids are the main agents used for analgesia. We therefore propose a single center study to fruther assess the efficacy of neuropathic agents in controlling the pain associated with acute thermal injury.

Condition or disease Intervention/treatment
Pain Burn Injury Drug: Gabapentin Drug: Placebo

Detailed Description:

The study was conducted in a 16-bed American Burn Association certified burn unit. Patients age >18 years old, with at least a 5% burn injury and an expected length of stay (LOS) of 48 hours, were approached for enrollment in this prospective, placebo controlled randomized study. Patients who were pregnant, lactating, prisoners or who had renal insufficiency were excluded. After consent, patients were assigned to either placebo or Gp by random numbers generated in Microsoft Excel (2010). Both the drug and the placebo were over-encapsulated to appear identical. The placebo pills contained starch. The research clinical pharmacist was the only unblinded staff member and did not participate in clinical care of the patients.

Following randomization, patients received a loading dose of study drug on day one and began three times a day (TID) dosing per the dose escalation schedule the following day. At discharge, patients were given a three day taper per the dose de-escalation schedule Patients were assessed for completion of psychosocial adjustment (Brief Symptom Inventory, BSI, and Sickness Inventory Profile, SIP) at their first clinic visit.

Agents used for pain control included: acetaminophen, non-steroidal anti-inflammatories, morphine instantaneous release and morphine extended release. In the case of allergies or ineffectiveness, other agents were occasionally used. Short acting morphine was ordered every two hours prn and hydromorphone was ordered every four hours as needed. All were converted to morphine equivalents.

The study was powered to detect a 22% difference in opioid consumption between the two groups based on the work by Cuignet et al. It was estimated that a total of 50 patients were needed to achieve an alpha of 0.05 and a beta of 0.80 to detect the difference in the primary endpoint.

For statistical purposes, conversion tables were used to convert all opioid medications into morphine equivalents with 1 morphine equivalents (ME)=30mg oral morphine. The primary outcome variable (morphine consumption) were adjusted for days past injury. The BSI and SIP scales were scored according to study directions.

Both an intention to treat and actual treatment analysis were performed using Stata 11.2 for Windows (Stata Corp. College Station, Texas, U.S.A.). Continuous variables between groups were analyzed with the students T test. Categorical variables were analyzed with the Chi Square test or Fischer Exact Test where appropriate. A random effects model adjusting for confounders was used to assess the effect of treatment on the outcome measures. The study was approved by the University's Institutional Review Board and was registered with the clinical trials association (200909736).


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Participant, Care Provider and Investigator are all masked.
Primary Purpose: Treatment
Official Title: The Effect of Neurontin on Pain Management in the Acutely Burned Patient
Actual Study Start Date : February 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Sugar Pill
Placebo
Drug: Placebo
Sugar Pill is administered similar to the protocol used for the investigational drug.
Experimental: Gabapentin
Gabapentin
Drug: Gabapentin

On Study day 1: 1200mg (single dose).

Study day 2,3: 300mg TID, 900mg daily.

Study day 4-7: 600mg TID 1800mg* daily.

Study day 8-11: 800mg TID 2400mg* daily [Optional increase to 2400 if pain scores are still 4 on NRS]

Study day 11: 1200mg TID 3600mg* daily [Optional increase to 3600 if pain scores are still >4 on NRS]

* May revert back to prior dose if adverse symptoms occur and are thought to be drug related. Up titration then will be preformed in 48 hours following deexcalation.

Other Name: Neurontin


Outcome Measures

Primary Outcome Measures :
  1. Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents) [ Time Frame: From time of enrollment to 2 weeks after being discharged ]

Secondary Outcome Measures :
  1. Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups [ Time Frame: First Clinic Follow Up After Discharge ]
    The Brief Symptom Inventory 18 (BSI 18) is designed with reliability in mind. The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders in medical and community populations. As the latest in an integrated series of test instruments that include the SCL-90-R®, BSI® (53 questions), and DPRS® instruments, the BSI 18 test offers a more effective, easy-to-administer tool to help support clinical decision-making and monitor progress throughout treatment. BSI-18 measures three dimensions with 6 questions a piece (somatization , depression , anxiety) and overall psychological distress scores (Global severity index, GSI). Each of the 18 items range from a score of 0-4; total score ranges from 0-72 with higher scores indicating worse function. The GSI score is calculated as the mean of the three subscales. The study reported the GSI score. Higher score is worse.

  2. Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP) [ Time Frame: First Clinic Follow Up After Discharge ]
    The sickness inventory profile (SIP) is a behaviorally based measure of health status. Scores range from 0-68 with higher numbers indicating worse outcomes. The study report total SIP score. The higher the score the worse the function.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All admitted patients with LOS expected to be > 48 hours (usually burn injury > 5%)
  • > 18 years of age
  • Thermal injury to skin

Exclusion Criteria:

  • Prisoners
  • Pregnant or nursing women
  • Children <18 years of age
  • Frostbite or non thermal injury to skin
  • Renal insuffiency (creatinine clearance < 60mL/min) or failure (on renal replacement)
  • Expected length of stay < 48 hours (this usually includes burn <5%
Contacts and Locations

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): NCT01265056


Locations
United States, Iowa
University of Iowa Burn Center
Iowa City, Iowa, United States, 52241
Sponsors and Collaborators
Lucy A Wibbenmeyer
Investigators
Principal Investigator: Lucy Wibbenmeyer, MD University of Iowa
More Information

Publications:
Responsible Party: Lucy A Wibbenmeyer, Associate Clinical Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01265056     History of Changes
Other Study ID Numbers: 200909736
First Posted: December 22, 2010    Key Record Dates
Results First Posted: February 26, 2013
Last Update Posted: January 23, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Researchers can contact me (lucy-wibbenmeyer@uiowa.edu) for study protocol or statistical plan.
Supporting Materials: Study Protocol
Time Frame: Data is available
Access Criteria: Email permission. Deidentified information only

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents