Pain intensity during hysteroscopy
Conditions
Interventions
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-
Ph
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Belgium
Contacts
Public ContactHIRUZ
Ghent University Hospital
Outcome results
None listed