Not Yet RecruitingPhase 4ACTRN12616001388404

A randomised controlled pilot trial to assess the efficacy of Intravesical Pethidine in treating bladder spasm in children who have undergone Ureteric Reimplantation Surgery


Sponsor

Princess Margaret Hospital

Enrollment

40 participants

Start Date

Nov 1, 2016

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 6 MonthssMax Age: 4 Yearss

Inclusion Criteria1

  • 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 Criteria1

  • Children whose parents refuse informed consent.

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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 adherenc

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.


Locations(1)

Princess Margaret Hospital - Subiaco

WA, Australia

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ACTRN12616001388404