Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Lior Lowenstein, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT02025166
First received: December 23, 2013
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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 Intervention
Pain
Drug: Paracetamol
Drug: lornoxicam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Pain [ Time Frame: Two hours ] [ Designated as safety issue: No ]
    Pain level will be evaluated by VAS


Estimated Enrollment: 82
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Lior Lowenstein, Gynecologist, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02025166     History of Changes
Other Study ID Numbers: RMB343-13, RMB0343-13
Study First Received: December 23, 2013
Last Updated: December 30, 2013
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Analgesics
Analgesics, Non-Narcotic
Acetaminophen
Lornoxicam
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014