Does gabapentin reduce itch in children with acute severe burns? A prospective randomised double blinded controlled study.

Phase 3

• Conditions: Pruritus; Acute burns in children; Injuries and Accidents - Burns; Skin - Dermatological conditions

• Registration Number: ACTRN12610000173099
• Lead Sponsor: Children's Hospital at Westmead

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients admitted to a burns ward.
Admission within 14 days of an acute burn injury.
Parenteral opioids required for analgesia.

Exclusion Criteria

Haemodynamic instability.
Previous or current treatment with gabapentin.
Receiveing Anti-epileptic drugs (AEDs).
Intubated and ventilated in a paediatric intensive care (PICU).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of itch during the last week of a four week treatment period.<br>Itch is present if 4 or more itch scores (of the seven recorded scores)are greater than 3 in the last week of observation.<br>Itch will be measured using a 10 point visual analogue scale (0= 'no itch', and 10 = worst possible itch').[Once per day during the last week of a four week treatment period.]

Secondary Outcome Measures

Name	Time	Method
Average itch score over the entire four week treatment period. Itch scores (either self-reported or reported by carers) will be documented in a diary supplied to all study recruits. Diary entries will be checked at weekly intervals through a phone interview and diaries will be collected for analysis at the end of the study period.[Itch is assessed daily during the four week treatment period.];Use of conventional rescue anti-pruritic medication. (Total number of doses of trimeperazine oral syrup given during the 28 day study period.)<br>Rescue medication will be available as per current clinical practice for persistent itch with scores >2)[Total over 28 day study period.];Parental satisfaction- assessed through a 5 point scale (0= completely dissatisfied, 4= completely satisfied)[At end of 28 day study period];Reported itch severity at 3 months after discharge. Assessed on a 10 point visual analogue scale.[At 3 months after discharge.]