A pilot study of gabapentin for managing pain in children with dystonic cerebral palsy
Murdoch Childrens Research Institute
20 participants
Nov 11, 2016
Interventional
Conditions
Summary
The primary objective of this feasibility pilot study is to gather preliminary data on the use of gabapentin to reduce pain in children with dystonic CP to inform a future RCT including trialling the recruitment process and retention rate, the outcome measures, and to identify complications and side effects from the medication which could impact on the design of an RCT. The study will specifically examine the variability of results for different outcome measures to determine effect sizes that will be used to inform the planning of a future trial (choice of primary outcome measure, sample size planning).
Eligibility
Inclusion Criteria3
- 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.
- 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.
- Pain will be quantified using the Health Utilities Index 3 (HUI 3). Those children scoring IV or V will be eligible.
Exclusion Criteria6
- Children excluded from the study will be those who:
- 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.
- Are currently on gabapentin or have been on gabapentin in the previous 3 months
- Have demonstrated hypersensitivity to gabapentin or the inactive ingredients in the capsules in the past
- Are currently taking other medications that may interact with gabapentin (i.e. antacid, cimetidine, morphine, and opioids).
- Pregnant female participants
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Intervention: Gabapentin Dose administered: The initial dosing regime will be the same for all participants. For all children, the dosage will be increased over 5 weeks as stated below: Week 1 – 100 mg daily Week 2 – 100 mg twice daily Week 3 - 200 mg twice daily Week 4 – 300 mg twice daily Week 5 – 300 mg three times a day However there is the potential for the dose to be escalated beyond this to a maximum of 50 mg/kg/day for heavier children, or for those children who have had no change in symptoms and have tolerated the medication. Dosage regime and escalation will be managed by the study doctor allocated to each participant. Duration of administration: 12 weeks Mode of administration: Orally, and for children who have a feeding tube in situ, the capsule contents will be dissolved in water and given via a gastrostomy, nasojejunal, gastrojejunal or nasogastric tube. Weekly phone calls to the study participants will be made by the study doctor to ensure that the dosage regime is being followed and to monitor tolerance to the medication. The hospital pharmacy will dispense the medication and will only provide families with the amount of medication required to take them to the next study assessment visit, whereby they will be provided with more depending on the dosage at that time point. Pharmacy will maintain records regarding when and how much study medication is dispensed by each patient in the study. Parents will be asked to return all unused capsules at each clinic visit. Reasons for departure from the expected dispensing regimen will be recorded. Any discrepencies will be investigated.
Locations(4)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12616000366459