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

NCT ID: NCT02416141

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-12-31

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.

Conditions

Fertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fast release oro-dispersible tramadol

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

Group Type: ACTIVE_COMPARATOR

fast release oro dispersible tramadol 50 mg

Intervention Type: DRUG

idem arm 1

Placebo-controlled arm

This group receives a placebo 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 placebo

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

fast release oro dispersible tramadol 50 mg

idem arm 1

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael De Brucker

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

UniversitairZB

Jette, , Belgium

Countries

Belgium

Central Contacts

Michael De Brucker, MD

Role: CONTACT

003224776699

Other Identifiers

CHUTIV2015MDB001

Identifier Type: -

Identifier Source: org_study_id