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

Phase 4

• Conditions: Vesicoureteric Reflux; Primary obstructive megaureter; Ureteric Reimplantation; Bladder Spasm; Bladder ureterocele; Surgery - Other surgery; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12616001388404
• Lead Sponsor: Princess Margaret Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Score. All patients will be assessed for pain (bladder spasm and wound scores) using standardised pain scores and pain assessment tools depending on their age and intellectual abilities by the ward nurses as well as by the research team. eg. Visual Analogue Scale, FPS-R (Faces Pain Scale - Revised),[Patients will be assessed for pain scores 2 hourly during the day and 4 hourly at night throughout the duration of their hospital admission. If the study drug (or placebo) is given they will be assessed: immediately prior to the instillation of the drug, during the installation of the drug, 5, 10, 15, 20, 30 and 60 min after the instillation. ]

Secondary Outcome Measures

Name	Time	Method
umber of episodes of breakthrough pain from bladder spasm. To be documented by nursing staff at time of episode.[During hospital admission post-operatively];Overall analgesia requirements. Opioid consumption (via the fentanyl infusion) as well as the use and doses of rescue analgesia will be recorded at each assessment.[Throughout hospital admission post-operatively];Intensity of bladder spasms. To be documented using standardised pain scores and pain assessment tools depending on their age and intellectual abilities by the ward nurses as well as by the research team. eg. Visual Analogue Scale, FPS-R (Faces Pain Scale - Revised),[During post operative admission in hospital To be measured immediately prior to the instillation of the drug, during the installation of the drug, 5, 10, 15, 20, 30 and 60 min after the instillation. ]