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

Information source: Universitair Ziekenhuis Brussel
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fertility

Intervention: fast release oro dispersible tramadol 50 mg (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Universitair Ziekenhuis Brussel

Official(s) and/or principal investigator(s):
Michael De Brucker, Principal Investigator, Affiliation: UZ Brussel

Overall contact:
Michael De Brucker, MD, Phone: 003224776699

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.

Clinical Details

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

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

Primary outcome: Will fast-release orodispersible tramadol reduce the pain (VAS) significantly in a vacuum aspiration procedure in this placebo-controlled trial.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

Locations and Contacts

Michael De Brucker, MD, Phone: 003224776699

UniversitairZB, Jette, Belgium
Additional Information

Starting date: April 2015
Last updated: April 8, 2015

Page last updated: August 23, 2015

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