None listed
Conditions
Brief summary
Aim: The aim is to assess the efficacy of intravesical pethidine in controlling bladder spasm in children after ureteric reimplantation surgery. Hypothesis: Children receiving intravesical pethidine will have less episodes of bladder spasm requiring therapy, lower pain scores and lower intravenous opioid requirements compared with children receiving placebo (saline) following ureteric reimplantation surgery
Interventions
Pethidine - intravesical, 1 mg/kg, as required up to every 4 hours post-operatively for bladder spasm until spasm resolved. Interventional drug to be administered by nursing staff and as such adherence will be monitored. Decision on whether drug to be given also made by nursing staff and/or clinician if available.
Sponsors
Princess Margaret Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Months to 4 Years
Healthy volunteers
No
Inclusion criteria
Children undergoing ureteric reimplantation surgery under general anaesthetic at Princess Margaret Hospital, Perth, Western Australia. Children will be enrolled pre-operatively and eligibility will not be dependent on whether they experience bladder spasm.
Exclusion criteria
Children whose parents refuse informed consent.
Outcome results
None listed