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
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