Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

• ClinicalTrials.gov Identifier: NCT02140970
• Recruitment Status: Recruiting
• First Posted: May 16, 2014
• Last Update Posted: February 18, 2021
• Sponsor: University of Colorado, Denver
• Collaborator: Children's Hospital Colorado
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Disorder of Urinary Stent; Ureteral Spasm; Ureteropelvic Junction Obstruction; Urolithiasis	Drug: Ibuprofen; Drug: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Double-blind, Placebo-controlled Randomized Controlled Trial of NSAID Prior to Ureteral Stent Removal in a Pediatric Population
• Study Start Date: May 2014
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Incidence of post-operative severe pain (pain score ≥ 7) [ Time Frame: 24 hours after stent removal ]

Secondary Outcome Measures :

1. Incidence of "significantly worsening" pain [ Time Frame: 24 hours after stent removal ]
   Incidence of "significantly worsening" pain is defined as any increase ≥ 2 between the pre-operative and post-operative pain scale assessments
2. Change in pre- and post-operative pain score [ Time Frame: 24 hours after stent removal ]
3. Opioid usage post-operatively [ Time Frame: 24 hours after stent removal ]
   This will be recorded in equivalents to milligrams intravenous morphine

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Sheryl Holbrook; sheryl.holbrook@ucdenver.edu

Contact: Jeffrey Campbell, MD; jeffrey.campbell@childrenscolorado.org

Locations

United States, Colorado

Children's Hospital Colorado; Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator: Jeffrey Campbell, MD

Sub-Investigator: Duncan Wilcox, MD, MBBS

Sub-Investigator: Vijay Vemulakonda, MD, JD

Sub-Investigator: Nicholas Cost, MD

Sub-Investigator: Kyle Rove, MD

Sub-Investigator: David Chalmers, MD

Sub-Investigator: Alan Bielsky, MD

Sponsors and Collaborators

University of Colorado, Denver

Children's Hospital Colorado

Investigators

• Principal Investigator: Jeffrey Campbell, MD; Children's Hospital Colorado

More Information

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.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02140970
• Other Study ID Numbers: 14-0514
• First Posted: May 16, 2014
• Last Update Posted: February 18, 2021
• Last Verified: February 2021

Keywords provided by University of Colorado, Denver:

ureteral stent; stent pain; ureteral spasm; NSAID; ibuprofen; placebo; ureteropelvic junction obstruction; urolithiasis

Additional relevant MeSH terms:

Urolithiasis; Hydronephrosis; Ureteral Obstruction; Multicystic Dysplastic Kidney; Urologic Diseases; Kidney Diseases; Ureteral Diseases; Urogenital Abnormalities; Kidney Diseases, Cystic; Congenital Abnormalities; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action