NCT02416141

Fast-release Orodispersible Tramadol as Analgesia in Termination of Pregnancy by Vacuum Aspiration.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fertility

Interventions

Type	Name	Description
DRUG	fast release oro dispersible tramadol 50 mg	idem arm 1

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-04-14
• Last updated: 2015-04-14

Locations

1 site across 1 country: Belgium