ifedipine induced pain relief during hysteroscopy

• Conditions: Pain during hysteroscopic examination or treatment. Pain caused by cervical dilatation. Pain caused by uterine cavity distension.

• Registration Number: NL-OMON20196
• Lead Sponsor: Investigator initiated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

At least 18 years of age, no medical history of cardiovascular disease, no hypotension; baseline blood pressure greater than or equal to 120/60 mmHg, otherwise healthy women with an average BMI (BMI<30), scheduled for a diagnostic hysteroscopy in outpatient setting

Exclusion Criteria

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 or kidney disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The intensity of pain scored by a visual analogue scale (VAS).

Secondary Outcome Measures

Name	Time	Method
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.