Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000173099
Ethics application status
Approved
Date submitted
4/01/2010
Date registered
25/02/2010
Date last updated
25/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Does gabapentin reduce itch in children with acute severe burns? A prospective randomised double blinded controlled study.
Scientific title
A comparison of two gabapentin doses with placebo for the management of itch in children with acute burns.
Secondary ID [1] 1325 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pruritus 252180 0
Acute burns in children 256462 0
Condition category
Condition code
Injuries and Accidents 252377 252377 0 0
Burns
Skin 252476 252476 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241613 0
Prevention
Comparator / control treatment
Placebo:
oral syrup (identical flavouring and natural colour so as to be identical to intervention) administered three times a day for 28 days.
Both study 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.
Control group
Placebo

Outcomes
Primary outcome [1] 253352 0
Presence of itch during the last week of a four week treatment period.
Itch is present if 4 or more itch scores (of the seven recorded scores)are greater than 3 in the last week of observation.
Itch will be measured using a 10 point visual analogue scale (0= 'no itch', and 10 = worst possible itch').
Timepoint [1] 253352 0
Once per day during the last week of a four week treatment period.
Secondary outcome [1] 262439 0
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.
Timepoint [1] 262439 0
Itch is assessed daily during the four week treatment period.
Secondary outcome [2] 263032 0
Use of conventional rescue anti-pruritic medication. (Total number of doses of trimeperazine oral syrup given during the 28 day study period.)
Rescue medication will be available as per current clinical practice for persistent itch with scores >2)
Timepoint [2] 263032 0
Total over 28 day study period.
Secondary outcome [3] 263037 0
Parental satisfaction- assessed through a 5 point scale (0= completely dissatisfied, 4= completely satisfied)
Timepoint [3] 263037 0
At end of 28 day study period
Secondary outcome [4] 263038 0
Reported itch severity at 3 months after discharge. Assessed on a 10 point visual analogue scale.
Timepoint [4] 263038 0
At 3 months after discharge.

Eligibility
Key inclusion criteria
Patients admitted to a burns ward.
Admission within 14 days of an acute burn injury.
Parenteral opioids required for analgesia.
Minimum age
1 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be identified by the primary investigators. Eligibility will be confirmed.
Following informed consent , a sealed opaque envelope containing an allocation code will be used. The hospital clinical trial pharmacist will hold the allocation schedule and will then dispense the study drug and maintain the blinding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by computerised sequence generation and will be stratified by age.
Randomisation will be completed in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2511 0
2145

Funding & Sponsors
Funding source category [1] 256230 0
Hospital
Name [1] 256230 0
Children's Hospital at Westmead
Country [1] 256230 0
Australia
Primary sponsor type
Hospital
Name
Children's Hospital at Westmead
Address
Hawkesbury Road
Westmead 2145
NSW
Australia
Country
Australia
Secondary sponsor category [1] 251562 0
Charities/Societies/Foundations
Name [1] 251562 0
Society of Paediatric Anaesthetists of New Zealand and Australia
Address [1] 251562 0
SPANZA secretariat
PO Box 180
Morisset
New South Wales 2264
Australia
Country [1] 251562 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258326 0
The Children's Hospital at Westmead Ethics Committee
Ethics committee address [1] 258326 0
The Children's Hospital at Westmead
Hawkesbury Road
Westmead 2145
NSW
Australia
Ethics committee country [1] 258326 0
Australia
Date submitted for ethics approval [1] 258326 0
Approval date [1] 258326 0
10/01/2010
Ethics approval number [1] 258326 0
09/CHW/152

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30499 0
Address 30499 0
Country 30499 0
Phone 30499 0
Fax 30499 0
Email 30499 0
Contact person for public queries
Name 13746 0
Dr Andrew Weatherall
Address 13746 0
c/o Dept of Anaesthesia
The Children's Hospital at Westmead
Hawkesbury Road
Westmead
NSW 2145
Australia
Country 13746 0
Australia
Phone 13746 0
61 2 9845 0000
Fax 13746 0
Email 13746 0
[email protected]
Contact person for scientific queries
Name 4674 0
Dr Andrew Weatherall
Address 4674 0
c/o Dept of Anaesthesia
The Children's Hospital at Westmead
Hawkesbury Road
Westmead
NSW 2145
Australia
Country 4674 0
Australia
Phone 4674 0
61 2 9845 0000
Fax 4674 0
Email 4674 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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