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

Fertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02416141
• Other study ID #: CHUTIV2015MDB001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 31, 2015
• Last updated: April 8, 2015
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Universitair Ziekenhuis Brussel
• Contact: Michael De Brucker, MD
• Phone: 003224776699
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fertility

Intervention

Drug:
• fast release oro dispersible tramadol 50 mg
idem arm 1

Locations

Country	Name	City	State
Belgium	UniversitairZB	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes