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Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion

NCT ID: NCT02025166

Last Updated: 2013-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain

Keywords

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Pain abortion paracetamol lornoxicam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paracetamol

Pain treatment, aniline analgesics

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

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

lornoxicam

Intervention Type DRUG

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

lornoxicam

Pain treatment, nonsteroidal anti-inflammatory (NSAID)

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

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

lornoxicam

Intervention Type DRUG

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

Interventions

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Paracetamol

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

Intervention Type DRUG

lornoxicam

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

Intervention Type DRUG

Other Intervention Names

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Pain relief Pain relief

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Lior Lowenstein

Gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susana Mustafa, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Nibal Awad, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Lior Lowenstein, MD, MS

Role: CONTACT

Phone: 97248542653

Email: [email protected]

Facility Contacts

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Lior Lowenstein, MD, MS

Role: primary

Other Identifiers

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RMB0343-13

Identifier Type: OTHER

Identifier Source: secondary_id

RMB343-13

Identifier Type: -

Identifier Source: org_study_id