Nifedipine as pain medication during hysteroscopy

INTERVENTION: Trade Name: Nifedipine CF Pharmaceutical Form: Capsule INN or Proposed INN: NIFEDIPINE CAS Number: 21829‐25‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Naproxen Sandoz Pharmaceutical Form: Tablet INN or Proposed INN: NAPROXEN Other descriptive name: NAPROXEN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ CONDITION: Pain intensity during hysteroscopy Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: 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. Primary end point(s): The intensity of pain scored by a visual analogue scale (VAS). Secondary Objective: Not applicable 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: 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. 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