NCT02025166

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

December 23, 2013

Last Update Submit

December 30, 2013

Conditions

Pain

Keywords

Painabortionparacetamollornoxicam

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain level will be evaluated by VAS

    Two hours

Study Arms (2)

Paracetamol

ACTIVE COMPARATOR

Pain treatment, aniline analgesics

Drug: ParacetamolDrug: lornoxicam

lornoxicam

ACTIVE COMPARATOR

Pain treatment, nonsteroidal anti-inflammatory (NSAID)

Drug: ParacetamolDrug: lornoxicam

Interventions

ParacetamolDRUG

Pain treatment with "aniline analgesics" (paracetamol) at the time of the procedure

Also known as: Pain relief
Paracetamollornoxicam
lornoxicamDRUG

Pain treatment with "NSAID" (lornoxicam) at the time of the procedure

Also known as: Pain relief
Paracetamollornoxicam

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Elective surgical abortion for first trimester pregnancy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

AcetaminophenAnalgesialornoxicam

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia and Analgesia

Study Officials

  • Susana Mustafa, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

  • Nibal Awad, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lior Lowenstein, MD, MS

CONTACT

97248542653l_lior@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecologist

Study Record Dates

First Submitted

December 23, 2013

First Posted

December 31, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations

IL(1)