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| Name | Class |
|---|---|
| Children's Hospital Colorado | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid ibuprofen | Experimental | 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal |
|
| Liquid placebo | Placebo Comparator | Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Campbell, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22578110 | Background | 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. |
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2 participants withdrew from the study prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liquid Ibuprofen | 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal |
| FG001 | 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 Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only participants who were analyzed are included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Liquid Ibuprofen | 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal |
| BG001 | Liquid Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 24 hours after stent removal |
|
Adverse event data were collected 30 days after exposure to the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liquid Ibuprofen | 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal Ibuprofen: 10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyle Rove | University of Colorado | 720 777 5893 | kyle.rove@childrenscolorado.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2017 | Mar 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C537373 | Multicystic renal dysplasia, bilateral |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal |
|
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 |
| Did not meet inclusion criteria |
|
Similar-tasting and appearing liquid placebo of equal volume to be given once orally 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Count of Participants | Participants | 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. | Posted | Mean | Full Range | score on a scale | 24 hours after stent removal |
|
|
|
| Secondary | Opioid Usage Post-operatively | This will be recorded in equivalents to milligrams intravenous morphine | Posted | Mean | Full Range | mg/kg | 24 hours after stent removal |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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 Placebo: Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal | 0 | 22 | 0 | 22 | 0 | 22 |
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| D052801 | Male Urogenital Diseases |