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

NCT01265056 | Completed Results

• 1 other identifier: 200909736
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Burn Injury

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents)

  From time of enrollment to 2 weeks after being discharged

Secondary Outcomes (2)

• Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups

  First Clinic Follow Up After Discharge

• Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP)

  First Clinic Follow Up After Discharge

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Gabapentin

EXPERIMENTAL

Gabapentin

Drug: Gabapentin

Interventions

Gabapentin DRUG

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.

Also known as: Neurontin

Gabapentin

Placebo DRUG

Sugar Pill is administered similar to the protocol used for the investigational drug.

Sugar Pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Lucy A Wibbenmeyer: lead

Study Sites (1)

University of Iowa Burn Center

Iowa City, Iowa, 52241, United States

Location

Related Publications (7)

• Gibran NS; Committee on Organization and Delivery of Burn Care, American Burn Association. Practice Guidelines for burn care, 2006. J Burn Care Res. 2006 Jul-Aug;27(4):437-8. doi: 10.1097/01.BCR.0000226084.26680.56. No abstract available.

  PMID: 16819344 BACKGROUND

• Cuignet O, Pirson J, Soudon O, Zizi M. Effects of gabapentin on morphine consumption and pain in severely burned patients. Burns. 2007 Feb;33(1):81-6. doi: 10.1016/j.burns.2006.04.020. Epub 2006 Oct 30.

  PMID: 17071002 BACKGROUND

• Summer GJ, Puntillo KA, Miaskowski C, Green PG, Levine JD. Burn injury pain: the continuing challenge. J Pain. 2007 Jul;8(7):533-48. doi: 10.1016/j.jpain.2007.02.426. Epub 2007 Apr 16.

  PMID: 17434800 BACKGROUND

• Dierking G, Duedahl TH, Rasmussen ML, Fomsgaard JS, Moiniche S, Romsing J, Dahl JB. Effects of gabapentin on postoperative morphine consumption and pain after abdominal hysterectomy: a randomized, double-blind trial. Acta Anaesthesiol Scand. 2004 Mar;48(3):322-7. doi: 10.1111/j.0001-5172.2004.0329.x.

  PMID: 14982565 BACKGROUND

• Gray P, Williams B, Cramond T. Successful use of gabapentin in acute pain management following burn injury: a case series. Pain Med. 2008 Apr;9(3):371-6. doi: 10.1111/j.1526-4637.2006.00149.x.

  PMID: 18366516 BACKGROUND

• Dworkin RH. An overview of neuropathic pain: syndromes, symptoms, signs, and several mechanisms. Clin J Pain. 2002 Nov-Dec;18(6):343-9. doi: 10.1097/00002508-200211000-00001.

  PMID: 12441827 BACKGROUND

• Dworkin RH, O'Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ, Portenoy RK, Rice ASC, Stacey BR, Treede RD, Turk DC, Wallace MS. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007 Dec 5;132(3):237-251. doi: 10.1016/j.pain.2007.08.033. Epub 2007 Oct 24.

  PMID: 17920770 BACKGROUND

MeSH Terms

Conditions

Pain; Burns

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

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: Jennifer Lassner
• Organization: The University of Iowa

jennifer-lassner@uiowa.edu

319-335-2123

Study Officials

• Lucy Wibbenmeyer, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participant, Care Provider and Investigator are all masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 22, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 23, 2018
• Results First Posted: February 26, 2013

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data is available
• Access Criteria: Email permission. Deidentified information only

Locations

US (1)