Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion

Pain Clinical Trial

Official title:

Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02025166
• Other study ID #: RMB343-13
• Secondary ID: RMB0343-13
• Status: Not yet recruiting
• Phase: N/A
• First received: December 23, 2013
• Last updated: December 30, 2013
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: December 2013
• Source: Rambam Health Care Campus
• Contact: Lior Lowenstein, MD, MS
• Phone: 97248542653
• Email: l_lior[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Paracetamol
Pain treatment with "aniline analgesics" (paracetamol) at the time of the procedure
• lornoxicam
Pain treatment with "NSAID" (lornoxicam) at the time of the procedure

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain level will be evaluated by VAS	Two hours	No