Fertility
Conditions
Brief summary
If a termination of pregnancy procedure is performed by vacuum aspiration our patients receive a paracervical block. Nevertheless these patients are not free of pain. We randomised our patients: one group will receive additional orodispersible tramadol, the other group will receive a placebo.
Detailed description
Patients were administered either 50 mg of fast-release orodispersible tramadol (Meda Pharma, Brussels, Belgium) or placebo 30 min before the procedure. Both, patient and gynecologist were blinded. Patients underwent the following procedure: a sterile bivalve speculum was introduced into the vagina, then cervix and vagina were washed with an antiseptic solution. The cervix was grasped with a tenaculum and straigthened. A paracervical block was achieved using a 27-gauge spinal needle. Lidocaine was injected and distributed equally around the cervicovaginal junction at 1, 5, 7 and 11 o'clock. The suction curettage was accomplished through the following steps: the cervix was dilated, in function of the gestation, to Hagar number 5 to 11 (Aesculap, Ag and Co. KG, Tuttlingen, Germany); The uterine depth was measured using a hysterometry; suction curettage was performed by using plastic canula (Luneau Sas, France) and a classic suction pump (AMEDA Egnell SA, Switserland). The patients were observed for 2 hours after the curettage procedure. Patients were asked to rate the pain during different steps of the procedure.
Interventions
idem arm 1
Sponsors
Study design
Eligibility
Inclusion criteria
* \- Patients above 18 ans. * Non desired pregnancy. * Non evolutive pregnancy. * Pregnancy \< or = 14 weeks of amenorrhea.
Exclusion criteria
* \- Interruption of pregnancy due to medical reasons * Patient already included in this study * Intolerance for Tradonal Odis 50mg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Will fast-release orodispersible tramadol reduce the pain (VAS) significantly in a vacuum aspiration procedure in this placebo-controlled trial. | 6 to 8 month to include all patients |
Countries
Belgium