Fast-release Orodispersible Tramadol as Analgesia in Termination of Pregnancy by Vacuum Aspiration.
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|ClinicalTrials.gov Identifier: NCT02416141|
Recruitment Status : Unknown
Verified March 2015 by Universitair Ziekenhuis Brussel.
Recruitment status was: Not yet recruiting
First Posted : April 14, 2015
Last Update Posted : April 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Fertility||Drug: fast release oro dispersible tramadol 50 mg||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Fast-release Orodispersible Tramadol as Analgesia in Termination of Pregnancy by Vacuum Aspiration.|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||December 2015|
Active Comparator: 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
Drug: fast release oro dispersible tramadol 50 mg
idem arm 1
Placebo Comparator: 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
- Will fast-release orodispersible tramadol reduce the pain (VAS) significantly in a vacuum aspiration procedure in this placebo-controlled trial. [ Time Frame: 6 to 8 month to include all patients ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416141
|Contact: Michael De Brucker, MD||003224776699|
|Principal Investigator:||Michael De Brucker||Universitair Ziekenhuis Brussel|