Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

Double-blind, Placebo-controlled Randomized Controlled Trial of NSAID Prior to Ureteral Stent Removal in a Pediatric Population

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis; Disorder of Urinary Stent; Ureteral Spasm; Ureteropelvic Junction Obstruction
• Intervention / Treatment: Drug: Ibuprofen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liquid ibuprofen; 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal	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 Comparator: Liquid placebo; Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal	Drug: Placebo; Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Opioid Usage Post-operatively	This will be recorded in equivalents to milligrams intravenous morphine	24 hours after stent removal

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Children's Hospital Colorado
• Investigators: Principal Investigator: Jeffrey Campbell, MD, Children's Hospital Colorado

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 11, 2020
• Study Completion (Actual): January 11, 2020

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 16, 2014

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: placebo; ibuprofen; NSAID; urolithiasis; ureteral stent; stent pain; ureteral spasm; ureteropelvic junction obstruction
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urogenital Abnormalities; Congenital Abnormalities; Pathological Conditions, Anatomical; Ureteral Diseases; Calculi; Kidney Diseases, Cystic; Urinary Calculi; Urolithiasis; Ureteral Obstruction; Multicystic Dysplastic Kidney; Hydronephrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 14-0514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No