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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
128
idem arm 1
UniversitairZB
Jette, Belgium
Will fast-release orodispersible tramadol reduce the pain (VAS) significantly in a vacuum aspiration procedure in this placebo-controlled trial.
Time frame: 6 to 8 month to include all patients
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