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Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain on Postoperative Pain

NCT ID: NCT02252614

Last Updated: 2014-09-30

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

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour after a lumbar disk surgery.

Detailed Description

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Patients were treated using patient-controlled analgesia with contramal for 24 hours after a lumbar disk surgery and randomized to receive IV naproksen sodium+codein, paracetamol+codein or isotonic saline (placebo).

The primary endpoint was pain intensity measured by the visual analogue scale, and secondary endpoints were contramal consumption and related side effects.

Conditions

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Postoperative Pain, PCA Contramal Consumption

Keywords

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naproxen sodium+codein, paracetamol+codein,lumbar disc surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Naproxen sodium codein

Preoperative Naproxen sodium codein administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.

Group Type ACTIVE_COMPARATOR

naproxen sodium codein

Intervention Type DRUG

Pain intensity, contramal consumption

Paracetamol codein

Preoperative paracetamol codein administrered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.

Group Type EXPERIMENTAL

paracetamol codein

Intervention Type DRUG

Pain intensity, contramal consumption

Placebo tablet

Preoperative placebo tablet administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pain intensity, contramal consumption

Interventions

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naproxen sodium codein

Pain intensity, contramal consumption

Intervention Type DRUG

paracetamol codein

Pain intensity, contramal consumption

Intervention Type DRUG

Placebo

Pain intensity, contramal consumption

Intervention Type DRUG

Other Intervention Names

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Apranax plus Geralgine K tablet Placebo tablet

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists 1 or 2 status patients scheduled for elective lumbar disk surgery under general anesthesia

Exclusion Criteria

* Patients, known allergies to any of the drugs used in this study
* eptic ulcer disease, hepatic and renal dysfunction, emergency surgery, or inability to provide informed consent (eg, mental disorders)
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Reyhan Polat

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reyhan Polat, MD

Role: PRINCIPAL_INVESTIGATOR

Diskapi YBERH

Central Contacts

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Reyhan Polat, MD

Role: CONTACT

Phone: +905326734310

Email: [email protected]

Other Identifiers

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DiskapiYBERH

Identifier Type: -

Identifier Source: org_study_id