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NCT06398054Not yet recruiting

A Study to Investigate the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducing Pain of Outpatient Hysteroscopy

Comparison of the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducing Pain of Outpatient Hysteroscopy: a Randomized, Phase iv, Double-blind Trial
ASST Fatebenefratelli SaccoPhase 4ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pain
Drug/Device/Intervention
Ibuprofen 400 mg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
ASST Fatebenefratelli Sacco
Timeline & enrollment
Phase
Phase 4
Start date
Oct 01, 2024
End date
Oct 01, 2026
Enrollment
190 participants
Primary outcome

Pain assessed by visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)

Summary

For outpatient hysteroscopy (OH), it is recommended to take a standard dose of NSAIDs or more
 hyoscine-n butyl bromide (HBB) an hour prior to the procedure to minimize pain during the
 first postoperative hour. As there is currently no clear consensus in the literature
 regarding the best approach to pain management associated with office hysteroscopy
 procedures. This Phase 4 study is being conducted to evaluate the effectiveness of oral
 ibuprofen alone and in combination with HBB to determine the most appropriate strategy for
 improving pain perception in outpatients.

ICD-10 classifications
Pain, unspecifiedPain, not elsewhere classifiedPain in limbAcute painOther chronic pain
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06398054
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06398054 through Pure Global AI's free database. This Phase 4 trial is sponsored by ASST Fatebenefratelli Sacco and is currently Not yet recruiting. The study focuses on Pain. Target enrollment is 190 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.