Fertility Clinical Trial
Official title:
Fast-release Orodispersible Tramadol as Analgesia in Termination of Pregnancy by Vacuum Aspiration.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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