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

Phase 4

• Conditions: Fertility
• Interventions: Drug: fast release oro dispersible tramadol 50 mg

• Registration Number: NCT02416141
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-31
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-08
• Last Update Submitted: 2015-04-08
• Study First Posted: 2015-04-14
• Last Update Posted: 2015-04-14
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fast release oro-dispersible tramadol	fast release oro dispersible tramadol 50 mg	This group receives a fast release oro-dispersible tramadol 30 minutes before the vacuum aspiration procedure. A paracervical block with a 27-gauge spinal needle with lidocaine will be injected at the the start of the procedure. Intervention: use of fast release oro dispersible tramadol 50 mg

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UniversitairZB; 🇧🇪 Jette, Belgium