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Naproxen Codeine in Arthroscopic Surgery

NCT ID: NCT01952652

Last Updated: 2013-09-30

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-07-31

Brief Summary

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In this study, the aim is to compare the efficacy of single dose naproxen sodium and combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more advantageous than naproxen alone.

Detailed Description

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Patients receiving preemptive oral naproxen sodium (Group N) or naproxen sodium-codeine phosphate (Group NC) were assigned in 2 groups.Preoperatively, drugs were given orally by a nurse unaware of the study to both groups within 60 minutes before surgery. Hemodynamic datas, possible side effects, pain and sedation levels of patients were recorded. Patient's pain and sedation levels were statistically assessed.

Conditions

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Arthroscopic Meniscus Surgery

Keywords

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Naproxen-codeine preemptive analgesia day case surgery

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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Group Naproxen sodium (Group N)

Group N received naproxen sodium 550 mg 60 minutes before surgery.

Group Type ACTIVE_COMPARATOR

Group N:Naproxen sodium

Intervention Type DRUG

drug will be given 60 minutes before surgery

Group Naproxen sodium codeine phosphate (Group NC)

Group NC received naproxen sodium 550 mg+30 mg codeine 60 minutes before surgery.

Group Type ACTIVE_COMPARATOR

Group NC :naproxen sodium codeine phosphate

Intervention Type DRUG

drug will be given 60 minutes before surgery

Interventions

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Group N:Naproxen sodium

drug will be given 60 minutes before surgery

Intervention Type DRUG

Group NC :naproxen sodium codeine phosphate

drug will be given 60 minutes before surgery

Intervention Type DRUG

Other Intervention Names

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Apranax fort tb, Abdi Ibrahim Ilaç,Turkiye Apranax plus tb, Abdi Ibrahim Ilac, Turkey

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing arthroscopic meniscectomy were included in the study.

Exclusion Criteria

* ≤ 18 years of age
* hypersensitivity to non-steroidal anti-inflammatory drugs and codeine,
* history of peptic ulcer, gastritis, upper gastrointestinal bleeding
* coagulation disorder
* serious hepatic and renal impairment
* pregnancy
* long-term NSAID and opioid use
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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CAGLA BALI,MD

MD,Anesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anis Aribogan, Prof.,MD

Role: STUDY_DIRECTOR

Baskent University School of Medicine

Locations

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Baskent University School of Medicine Adana Teaching and Research Hospital

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KA12/268

Identifier Type: -

Identifier Source: org_study_id