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Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

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ClinicalTrials.gov Identifier: NCT02140970
Recruitment Status : Recruiting
First Posted : May 16, 2014
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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
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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 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140970


Contacts
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Contact: Sheryl Holbrook sheryl.holbrook@ucdenver.edu
Contact: Jeffrey Campbell, MD jeffrey.campbell@childrenscolorado.org

Locations
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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
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Principal Investigator: Jeffrey Campbell, MD Children's Hospital Colorado
More Information
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Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02140970     History of Changes
Other Study ID Numbers: 14-0514
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

Keywords provided by University of Colorado, Denver:
ureteral stent
stent pain
ureteral spasm
NSAID
 ibuprofen
placebo
ureteropelvic junction obstruction
urolithiasis

Additional relevant MeSH terms:
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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