None listed
Conditions
Brief 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.
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 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
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.
Sponsors
Children's Hospital at Westmead
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
1 Years to 16 Years
Healthy volunteers
No
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).
Outcome results
None listed