Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion

December 30, 2013 updated by: Lior Lowenstein, Rambam Health Care Campus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus
        • Contact:
        • Principal Investigator:
          • Susana Mustafa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Pain relief
Drug: lornoxicam
Pain treatment with "NSAID" (lornoxicam) at the time of the procedure
Other Names:
  • 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 Names:
  • Pain relief
Drug: lornoxicam
Pain treatment with "NSAID" (lornoxicam) at the time of the procedure
Other Names:
  • Pain relief

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Two hours
Pain level will be evaluated by VAS
Two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Susana Mustafa, MD, Rambam Health Care Campus
  • Principal Investigator: Nibal Awad, MD, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

December 23, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Estimate)

December 31, 2013

Last Update Submitted That Met QC Criteria

December 30, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMB343-13
  • RMB0343-13 (Other Identifier: Helsinki)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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