Not Yet RecruitingPhase 3ACTRN12610000173099

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

A comparison of two gabapentin doses with placebo for the management of itch in children with acute burns.

Sponsor

Children's Hospital at Westmead

Enrollment

90 participants

Start Date

Mar 15, 2010

Study Type

Interventional

Conditions

Acute burns in children Pruritus

Summary

This randomised, placebo-controlled and blinded study aims to quantify the effect of regular oral gabapentin (28 day course) on the incidence and severity of pruritus in children with acute severe burns. Itch will be assessed using standardised age appropriate itch scales. The primary outcome measure will be the proportion of children who are itch free in the final week of a four week study period. Secondary outcomes will include the average severity of itch during the four week study period and the use of conventional rescue anti-pruritic medication. Other secondary outcomes include parental satisfaction and reported pruritus severity at 3months after discharge (obtained through a follow-up phone interview). Although not the primary focus of this study, the effect of gabapentin on pain scores and opioid requirements in these patients will be explored. The is a single-centre, investigator-driven study that will be conducted within the Burns Unit at the Children’s Hospital at Westmead, which is the referral centre for all children with burns in New South Wales. Modest financial support for this study has been obtained from the Society of Paediatric Anaesthetists of New Zealand and Australia.

Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether gabapentin (a nerve pain medication) can reduce itching in children with severe burn injuries. It is for children aged 1 to 16 who have been admitted to a burns ward within 14 days of an acute burn and need strong pain medication.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Gabapentin oral, two dose regimens: Group 1: oral gabapentin syrup 5mg/kg three times a day for 28 days. Group 2: oral gabapentin syrup 10mg/kg three times a day for 28days. Both groups and the con

Gabapentin oral, two dose regimens: Group 1: oral gabapentin syrup 5mg/kg three times a day for 28 days. Group 2: oral gabapentin syrup 10mg/kg three times a day for 28days. Both groups and the control group will have access to rescue medication for peristent itch. The rescue medication reflects current clinical practice i.e. trimeprazine 0.5mg/kg oral up to every 8hours. N.b. the study intervention tests a 'preventative action' on itch. Itch that occurs despite the study drug intervention will be managed according to a standard protocol i.e. a 'rescue protocol- given below. Standardised management of itch in children with burns. The management of itch will be standardised and include both non-pharmacological and pharmacological interventions. Non-pharmacological interventions include the use of pressure garments where appropriate, skin and scar lubrication if appropriate (healed burns or donor sites), soft tissue mobilisation or massage and play and distraction therapies. Pharmacological intervention will be standardised into three sequential tiers of rescue interventions reflecting current clinical practice. I) Itch score > 2: Trimeprazine 0.5 mg/kg orally tds for 48 hours. II) Itch unresponsive to anti-histamine :Ondansetron 0.1 mg/kg orally or IV tds for 24 hours. III) Persistent itch. Itch causing distress more than 72 hours after commencing anti-histamine: IV naloxone infusion. 0.5/micrograms/kg/hour for 12 hours. Study drug treatment will continue for 28 days unless a side-effect or adverse event suspected to be related to the study drug is detected.