Cystitis Clinical Trial
Official title:
Efficacy of Oxybutynin in Paediatric Cystitis
NCT number | NCT03877289 |
Other study ID # | OxyRCT1 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | October 2008 |
Est. completion date | July 2014 |
Verified date | December 2022 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary goal of this study is to determine if the addition of the bladder antispasmotic oxybutynin to standard antimicrobial therapy in the treatment of childhood cystitis will decrease the associated pain and discomfort. A randomized, double blind, placebo-controlled clinical trial design will be used. The second goal of this study will be to describe the nature and duration of symptoms associated with uncomplicated cystitis in the paediatric age group. Finally, adverse side effects associated with short term use of oxybutynin will be monitored.
Status | Completed |
Enrollment | 81 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 16 Years |
Eligibility | Inclusion Criteria: 1. Age 4 - 16 years 2. Suspected diagnosis of cystitis based on a clean catch or catheter urinalysis (must have at least one of the three screening tests positive - leukocyte esterase, nitrites, or leukocytosis or bactiuria on microscopy) 3. Intention to manage patient as an out-patient with oral antibiotics 4. Parent must be available to assist younger children with the measurements for 24 hours and must be willing to receive follow-up calls daily until symptoms resolve 5. Written informed consent (and assent when age-appropriate) Exclusion Criteria: 1. Clinically suspected pyelonephritis (ED temperature > 38.5, significant flank pain, vomiting > 3 times/24 hours) 2. Patient not toilet trained 3. Patient with significant language delays (preventing use of the facial pain scale) 4. Patient with sensory deficits at the sacral level 5. Inability of the patient and parent to speak and understand English 6. Known contraindication to Oxybutynin (hypersensitivity, glaucoma, bowel obstruction, megacolon, ulcerative colitis, myesthenia gravis, renal or hepatic disease, hyperthyroidism, heart disease, and obstructive uropathy) 7. Patient on any medications during the preceding 8 hours that have analgesic or anticholinergic properties (acetominophen, and inhaled medications will be permitted) 8. Patients who have been previously enrolled in the study 9. Lack of a telephone in the home 10. Known or suspected pregnancy or lactation in the patient 11. Treating physician uses pyridium |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain/discomfort ratings obtained at 4 hours after each of the three doses of study medication. | Participants will be asked to rate how they feel at each of these times using the McGrath Facial Affective Scale (MFAS). The MFAS ranges from the lowest pain score A (happy face) to the highest pain score I (very unhappy crying face). Data will be acquired over a 4 hours after the oxybutynin is given, therefore the investigators can expect that some of the measurements will be disrupted by nighttime sleep for some of the participants. Parents will be asked to document if their child is sleeping during the time when measurements are to be made. | Four hours after each of the three doses of study medication. | |
Secondary | Measurements of pain/discomfort with each urination recorded during the first 24 hours. | Measurements will be made using the McGrath Facial Affective Scale and will be recorded by the participant or family member at home. | Immediate 24 hours after presenting to the ED. | |
Secondary | Number of supplemental doses of acetominophen used during the first 24 hours of the study. | This information will be recorded by the participant or caregiver at home. | Immediate 24 hours after presenting to the ED. |
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