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

Universitair Ziekenhuis Brussel

Status and phase: Unknown; Phase 4

Conditions: Fertility

Treatments: Drug: fast release oro dispersible tramadol 50 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02416141

CHUTIV2015MDB001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups, including a placebo group

Fast release oro-dispersible tramadol

Active Comparator group

Description:

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

Treatment:

Drug: fast release oro dispersible tramadol 50 mg

Placebo-controlled arm

Placebo Comparator group

Description:

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