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

Condition(s) targeted: Pain Management; Burn Patient

Intervention: Gabapentin (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Iowa

Official(s) and/or principal investigator(s):
Lucy Wibbenmeyer, MD, Principal Investigator, Affiliation: University of Iowa
Anas Eid, MD, Study Director, Affiliation: University of Iowa

Overall contact:
Anas A Eid, MD, Phone: 3193561304, Email: anas-eid@uiowa.edu

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: To determine the trends in opioid consumption between the treatment and the control groups.

Secondary outcome:

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

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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%

Anas A Eid, MD, Phone: 3193561304, Email: anas-eid@uiowa.edu

University of Iowa Burn Center, Iowa City, Iowa 52241, United States; Recruiting

Related publications:

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. No abstract available.

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. Epub 2006 Oct 30.

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

Dierking G, Duedahl TH, Rasmussen ML, Fomsgaard JS, Møiniche S, Rømsing 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.

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.

Dworkin RH. An overview of neuropathic pain: syndromes, symptoms, signs, and several mechanisms. Clin J Pain. 2002 Nov-Dec;18(6):343-9. Review.

Dworkin RH, O'Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ, Portenoy RK, Rice AS, Stacey BR, Treede RD, Turk DC, Wallace MS. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007 Dec 5;132(3):237-51. Epub 2007 Oct 24. Review.

Starting date: February 2010
Last updated: December 21, 2010