Pain during hysteroscopic examination or treatment. Pain caused by cervical dilatation. Pain caused by uterine cavity distension.
Conditions
Interventions
Nifedipine, naproxen or placebo
Sponsors
Investigator initiated
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The intensity of pain scored by a visual analogue scale (VAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactLisa Verheul
Universitair Medisch Centrum Utrecht
Outcome results
None listed