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Trial record 25 of 451 for:    TRAMADOL

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
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Brief 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.

Condition or disease Intervention/treatment Phase
Fertility Drug: fast release oro dispersible tramadol 50 mg Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Michael De Brucker, MD 003224776699

Locations
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Belgium
UniversitairZB
Jette, Belgium
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Michael De Brucker Universitair Ziekenhuis Brussel

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02416141     History of Changes
Other Study ID Numbers: CHUTIV2015MDB001
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents