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Pain and Suction Curettage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01947205
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Gökhan Açmaz, Kayseri Education and Research Hospital

Brief Summary:
Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine on curettage procedure.

Condition or disease Intervention/treatment Phase
Curettage Analgesia Paracervical Block Paracetamol Drug: paracetamol Drug: dexketoprofen trometamol Drug: suction curettage Other: without drug Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Active Comparator: paracetamol
Duration
Drug: paracetamol
Active Comparator: without drug
Control group
Other: without drug
Active Comparator: dexketoprofen trometamol
Study group
Drug: dexketoprofen trometamol
Active Comparator: two puff xylocain administration on cervical surface
Study group
Drug: suction curettage
Other Name: two puff xylocain administration

Active Comparator: paracervical block with ultracaine
study group
Drug: suction curettage
Other Name: paracervical block with ultracaine




Primary Outcome Measures :
  1. pain reduction [ Time Frame: nine months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant participants between 35-48 days of gestation (5 to 7 weeks of gestation) pregnant participants with a single viable intrauterine pregnancy requesting termination of pregnancy.

Exclusion Criteria:

incomplete abortions, diabetes mellitus, tendency to bleed such as thrombocytopenia, factor deficiency and functional disorders of platelets… etc, pelvic infection, known cervical stenosis, significantly impaired respiratory or cardiac conduction functions, active liver disease, renal disease, previous adverse reaction to any of the drugs used in the study, and patients who are unable to understand how to score a 10-cm visual analog scale (VAS) pain score. Moreover, patients who described chronic pelvic pain prior to the study or patients who rated their pain level on a continuous 100-mm VAS different from 0 (no pain) just before the study were not included into study.


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): NCT01947205


Locations
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Turkey
Kayseri Education and Research Hospital of Medicine
Kayseri, Turkey, 38039
Sponsors and Collaborators
Gökhan Açmaz
Investigators
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Principal Investigator: Gökhan Açmaz, MD Kayseri Education and Research Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gökhan Açmaz, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01947205    
Other Study ID Numbers: Kayseri ERH
KayseriERH ( Other Identifier: KayseriERH )
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013
Keywords provided by Gökhan Açmaz, Kayseri Education and Research Hospital:
Curettage
analgesia
paracervical block
paracetamol
lidocaine
Dexketoprofen trometamol
Additional relevant MeSH terms:
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Acetaminophen
Dexketoprofen trometamol
Ketoprofen
Carticaine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants