Disorder of Urinary Stent, Ureteral Spasm, Ureteropelvic Junction Obstruction, Urolithiasis
Conditions
Keywords
ureteral stent, stent pain, ureteral spasm, NSAID, ibuprofen, placebo, ureteropelvic junction obstruction, urolithiasis
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.
Interventions
DRUGIbuprofen
10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
DRUGPlacebo
Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
Sponsors
Children's Hospital Colorado
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-operative Severe Pain (Pain Score ≥ 7) | 24 hours after stent removal | Two pain scales were used (Faces pain scale-revised \[FPS-R\] and visual analogue scale \[VAS\]) and converted to continuous value 0-10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Significantly Worsening Pain | 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 |
| Change in Pre- and Post-operative Pain Score | 24 hours after 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. |
| Opioid Usage Post-operatively | 24 hours after stent removal | This will be recorded in equivalents to milligrams intravenous morphine |
Countries
United States
Participant flow
Pre-assignment details
2 participants withdrew from the study prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet inclusion criteria | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Misplaced consent, subject withdrawn | 1 | 0 |
Baseline characteristics
| Characteristic | Liquid Placebo | Total | Liquid Ibuprofen |
|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 44 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.2 years | 11.4 years | 10.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 42 Participants | 21 Participants |
| Region of Enrollment United States | 22 participants | 44 participants | 22 participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
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.
Time frame: 24 hours after stent removal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liquid Ibuprofen | Incidence of Post-operative Severe Pain (Pain Score ≥ 7) | 2 Participants |
| Liquid Placebo | Incidence of Post-operative Severe Pain (Pain Score ≥ 7) | 1 Participants |
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.
Time frame: 24 hours after stent removal
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Liquid Ibuprofen | Change in Pre- and Post-operative Pain Score | 0.4 score on a scale |
| Liquid Placebo | Change in Pre- and Post-operative Pain Score | 0.2 score on a scale |
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
Time frame: 24 hours after stent removal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liquid Ibuprofen | Incidence of Significantly Worsening Pain | 3 Participants |
| Liquid Placebo | Incidence of Significantly Worsening Pain | 5 Participants |
Secondary
Opioid Usage Post-operatively
This will be recorded in equivalents to milligrams intravenous morphine
Time frame: 24 hours after stent removal
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Liquid Ibuprofen | Opioid Usage Post-operatively | 0.0 mg/kg |
| Liquid Placebo | Opioid Usage Post-operatively | 0.0 mg/kg |