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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02140970
Other study ID # 14-0514
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date January 11, 2020

Study information

Verified date March 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study plans to learn more about whether ibuprofen can reduce pain after removal of a ureteral stent more than a placebo. Some patients experience pain after removal of a ureteral stent. The investigators plan to learn how often this occurs and whether it can be prevented. The investigators hypothesize that children who have a temporary, indwelling ureteral stent will experience a significantly less post-operative pain if given a non-steroidal anti-inflammatory (NSAID) prior to removal of the ureteral stent when compared to placebo. The investigators hypothesize that the incidence of severe post-stent removal pain is similar to an adult population.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 11, 2020
Est. primary completion date January 11, 2020
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility Inclusion Criteria: - ages 4-17 - unilateral ureteral stent placed after ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis Exclusion Criteria: - bilateral stents - undergoing other concomitant procedure at time of planned ureteral stent removal - indication for stent other than ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis - pregnant - developmental delay - allergy to ibuprofen or non-steroidal anti-inflammatory medication class - chronic kidney disease - prior renal transplant - history of nasal polyps - history of asthma

Study Design


Intervention

Drug:
Ibuprofen
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
Placebo
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal

Locations

Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tadros NN, Bland L, Legg E, Olyaei A, Conlin MJ. A single dose of a non-steroidal anti-inflammatory drug (NSAID) prevents severe pain after ureteric stent removal: a prospective, randomised, double-blind, placebo-controlled trial. BJU Int. 2013 Jan;111(1):101-5. doi: 10.1111/j.1464-410X.2012.11214.x. Epub 2012 May 11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Post-operative Severe Pain (Pain Score = 7) Two pain scales were used (Faces pain scale-revised [FPS-R] and visual analogue scale [VAS]) and converted to continuous value 0-10. 24 hours after stent removal
Secondary Incidence of "Significantly Worsening" Pain Incidence of "significantly worsening" pain is defined as any increase = 2 between the pre-operative and post-operative pain scale assessments 24 hours after stent removal
Secondary Change in Pre- and Post-operative Pain Score Pain will be assessed via a 10 point [NAME OF SCALE] scale. Possible scores range from 0 to 10, with higher scores indicating more severe pain and a worse outcome. 24 hours after stent removal
Secondary Opioid Usage Post-operatively This will be recorded in equivalents to milligrams intravenous morphine 24 hours after stent removal
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