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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wibbenmeyer, Lucy A, University of Iowa
ClinicalTrials.gov Identifier:
NCT01265056
First received: December 20, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

Burn patients have extreme pain. Opioids are the main agents used for analgesia. Opioids can have several adverse outcomes and have been only partially effective in controlling the pain assoicated with burn injury. Agents directed at neuropathic pain are rarely used acutely in thermal injury. However, there is mounting evidence from small randomized clinical studies that the administration of the anticonvulsant Gabapentin decreases acute burn pain and has an opioid sparing effect. We therefore propose a single center study to fruther assess the efficacy of neuropathic agents in controlling the pain assoicated with acute thermal injury.


Condition Intervention
Pain Management
Burn Patient
Drug: Gabapentin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Neurontin on Pain Management in the Acutely Burned Patient

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • To Determine the Trends in Opioid Consumption Between the Treatment and the Control Groups. [ Time Frame: From time of enrollment to 2 weeks after being discharged ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Determine the Trends in Several Associated Clinical Effects of Opioid Administration Between the Treatment and the Control Groups. These Effects Include: 1. Fluid Resusitation 2. Insulin Resistance 3. Hospital Associated Infections [ Time Frame: From time of enrollment to 2 weeks after being discharge ] [ Designated as safety issue: No ]
  • To Determine the Impact of Psychological Functioning in Patients Following Admission for Their Burn Injury. This Will be Determined by Review of Two Forms (the Brief Symptom Inventory and the Sickness Impact Profile). [ Time Frame: From time of enrollment to 2 weeks after being discharge ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill Drug: Placebo
Sugar Pill is administered similar to the protocol used for the investigational drug.
Experimental: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265056

Locations
United States, Iowa
University of Iowa Burn Center
Iowa City, Iowa, United States, 52241
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Lucy Wibbenmeyer, MD University of Iowa
Study Director: Karen Kluesner, RN University of Iowa
  More Information

Publications:
Responsible Party: Wibbenmeyer, Lucy A, Associate Clinical Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01265056     History of Changes
Other Study ID Numbers: 200909736
Study First Received: December 20, 2010
Results First Received: January 22, 2013
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014