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Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion

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ClinicalTrials.gov Identifier: NCT02025166
Recruitment Status : Unknown
Verified December 2013 by Lior Lowenstein, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Lior Lowenstein, Rambam Health Care Campus

Brief Summary:

To compare between the efficacy of Paracetamol IV vs. Lornoxicam IV in pain relief following surgical abortion.

The medication will be given at the time of the procedure. Following the abortion, pain level will be evaluated.


Condition or disease Intervention/treatment
Pain Drug: Paracetamol Drug: lornoxicam

Detailed Description:

Patients with medical indication for surgical abortion during first trimester will be divided to two groups. The study groups, the surgeons and the nurses will be blinded to one of the treatment arms.

Pain will be evaluated at fixed intervals following the abortion. Comparison in pain levels between the study groups will be analysed.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion
Study Start Date : January 2014
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Arm Intervention/treatment
Active Comparator: Paracetamol
Pain treatment, aniline analgesics
Drug: Paracetamol
Pain treatment with "aniline analgesics" (paracetamol) at the time of the procedure
Other Name: Pain relief
Drug: lornoxicam
Pain treatment with "NSAID" (lornoxicam) at the time of the procedure
Other Name: Pain relief
Active Comparator: lornoxicam
Pain treatment, nonsteroidal anti-inflammatory (NSAID)
Drug: Paracetamol
Pain treatment with "aniline analgesics" (paracetamol) at the time of the procedure
Other Name: Pain relief
Drug: lornoxicam
Pain treatment with "NSAID" (lornoxicam) at the time of the procedure
Other Name: Pain relief



Primary Outcome Measures :
  1. Pain [ Time Frame: Two hours ]
    Pain level will be evaluated by VAS



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective surgical abortion for first trimester pregnancy

Exclusion Criteria:

  • Chronic pelvic pain
  • Fibromyalgia
  • Pelvic inflammatory disease
  • Chronic renal failure, liver disease, peptic ulcer
  • cervical stenosis

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): NCT02025166


Contacts
Contact: Lior Lowenstein, MD, MS 97248542653 l_lior@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Not yet recruiting
Haifa, Israel
Contact: Lior Lowenstein, MD, MS    972502061434    l_lior@rambam.health.gov.il   
Principal Investigator: Susana Mustafa, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Susana Mustafa, MD Rambam Health Care Campus
Principal Investigator: Nibal Awad, MD Rambam Health Care Campus

Responsible Party: Lior Lowenstein, Gynecologist, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02025166     History of Changes
Other Study ID Numbers: RMB343-13
RMB0343-13 ( Other Identifier: Helsinki )
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

Keywords provided by Lior Lowenstein, Rambam Health Care Campus:
Pain
abortion
paracetamol
lornoxicam

Additional relevant MeSH terms:
Analgesics
Acetaminophen
Lornoxicam
Piroxicam
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action