ifedipine as pain medication during hysteroscopy

Phase 1

• Conditions: Pain intensity during hysteroscopy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-001020-19-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-27
• Study Completion: 2022-12-01
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria: at least 18 years of age, no medical history of cardiovascular disease, no hypotension; baseline blood pressure greater than or equal to 110/60 mmHg, otherwise healthy women with an average BMI (BMI=35), scheduled for a diagnostic hysteroscopy in outpatient setting.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study: 50 years of age or older, pregnant or lactating (will be checked by asking the patient), daily use of pain medication (NSAIDs, paracetamol, opioids) or nifedipine or other calcium re-entry blockers, history of complications or adverse effects when using NSAIDs, nifedipine or other calcium re-entry blockers, previously diagnosed hypotension, the use of cardiovascular medication, CYP3A4-inhibitors, rifampicin or magnesium sulfate, previously diagnosed liver disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the study is to compare the pain intensity during hysteroscopy after using nifedipine as pain medication versus using naproxen or placebo.;Secondary Objective: Not applicable;Primary end point(s): The intensity of pain scored by a visual analogue scale (VAS).;Timepoint(s) of evaluation of this end point: During the insertion of the instrument, during the procedure, at the end of the procedure (after removing the scope) and 30 minutes after the hysteroscopy.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The experienced adverse effects after using nifedipine monitored until 30 minutes after the hysteroscopy by a questionnaire and evaluated the day after the hysteroscopy by phone. Complications during the hysteroscopy are also considered as secondary outcomes.;Timepoint(s) of evaluation of this end point: Until 30 minutes after the hysteroscopy and the day after hysteroscopy.