A pilot study of gabapentin for managing pain in children with dystonic cerebral palsy

Phase 3

Completed

• Conditions: Dystonic cerebral palsy; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Anaesthesiology - Pain management; Neurological - Other neurological disorders

• Registration Number: ACTRN12616000366459
• Lead Sponsor: Murdoch Childrens Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-22
• Study Completion: 2019-01-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1)Confirmation of dystonia after completion of the Hypertonicity Assessment Tool (HAT). Those children who have dystonia or a mixed diagnosis (spasticity and dystonia) will be eligible.
2)Severity of dystonia will be determined with the Barry Albright Dystonia (BAD) scale. Children with a score of 15 or higher on the BAD scale will be eligible.
3)Pain will be quantified using the Health Utilities Index 3 (HUI 3). Those children scoring IV or V will be eligible.

Exclusion Criteria

Children excluded from the study will be those who:
1.Are younger than 6 years because they will have more difficulty with reliably self-reporting and will not be able to perform some of the quantitative measurements.
2.Are currently on gabapentin or have been on gabapentin in the previous 3 months
3.Have demonstrated hypersensitivity to gabapentin or the inactive ingredients in the capsules in the past
4.Are currently taking other medications that may interact with gabapentin (i.e. antacid, cimetidine, morphine, and opioids).
5.Pregnant female participants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This is a feasibility pilot study, and the main objective is to gather preliminary data on gabapentin for managing pain in children with dystonic CP to inform a future RCT. This will include trialling the recruitment process. There will be a composite feasibility outcome of recruitment number, recruitment rate and retention rate, all assessed by review of study records.[At conclusion of study - 12 weeks];Complications and side effects of the medication, will be assessed by review of daily medication logs completed by parents. For example, possible side-effects such as drowsiness and confusion, upset stomach, weakness, mood or behaviour changes will be recorded by parents on the daily medication diaries. [At conclusion of study - 12 weeks (but side-effects and complications and feedback from parents will all be closely monitored by the study doctors on a weekly basis).]

Secondary Outcome Measures

Name	Time	Method
Pain Measured by: Faces Pain Scale – Revised (FPS-R), Pediatric Pain Profile (PPP), Weekly pain diary <br>[Baseline, 6 weeks, and 12 weeks];Comfort<br>Measured by:<br>Care and Comfort Hypertonicity Questionnaire (CCHQ)<br>The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD)[Baseline, 6 weeks, and 12 weeks ];Dystonia<br>Measured by:<br>Barry Albright Dystonia (BAD) Scale<br>Health Utilities Index 3 (HUI 3) Multi-Attribute Health Status Classification System[BAD Scale - Baseline, 6 weeks, and 12 weeks.<br>HUI-3 - Screening/baseline, and 12 weeks]