Phase 4 N=71 Randomized Quadruple-blind Treatment

The Use of Belladonna and Opium Suppository in the Treatment of Postoperative Stent Pain

Nephrolithiasis

Bottom Line

View on ClinicalTrials.gov: NCT03332056 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Global Quality of Life Score on Postoperative Day 1 — 4.4; 5.4 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Belladonna and Opium (Drug); Placebo suppository (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Global Quality of Life Score on Postoperative Day 1	4.4; 5.4	—
PRIMARY Global Quality of Life Score on Postoperative 3	4.5; 5.6	—
SECONDARY Number of Participants With Postoperative Complications as a Result of the Use of B&O Suppository	—	—
SECONDARY Number of Participants With Unanticipated Postoperative Visits	3; 5	—
SECONDARY Measurement of Post-operative Narcotic Use	55; 65	—

Summary

The purpose of this study is to determine if preemptive B&O suppository placement will decrease post-operative pain in patients undergoing ureteral stent placement.

Eligibility Criteria

Inclusion Criteria

patients who will receive ureteroscopy with concurrent placement of a ureteral stent.

Exclusion Criteria

age < 18,
neurologic deficits of any kind
non-English speaking patients.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03332056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.