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A Study to Investigate the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducing Pain of Outpatient Hysteroscopy - Trial NCT06398054

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.

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NCT06398054
Phase 4
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06398054
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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

Study Focus

Pain

Ibuprofen 400 mg

Interventional

drug

Sponsor & Location

ASST Fatebenefratelli Sacco

Timeline & Enrollment

Phase 4

Oct 01, 2024

Oct 01, 2026

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, unspecified
Pain, not elsewhere classified
Pain in limb
Acute pain
Other chronic pain

Data Source

ClinicalTrials.gov

NCT06398054

Non-Device Trial