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Naproxen Codeine in Arthroscopic Surgery

Information source: Baskent University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthroscopic Meniscus Surgery

Intervention: Group N:Naproxen sodium (Drug); Group NC :naproxen sodium codeine phosphate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Baskent University

Official(s) and/or principal investigator(s):
Anis Aribogan, Prof.,MD, Study Director, Affiliation: Baskent University School of Medicine

Summary

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.

Clinical Details

Official title: Comparison of Post-operative Analgesic Effects of Naproxen Sodium and Naproxen Sodium-codeine Phosphate Administered Preemptively for Arthroscopic Meniscus Surgery

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

Primary outcome: Pain scores as measured by Visual Analogue Scale were significantly lower in Group Naproxen codeine (group NC) at all time points compared to Group Naproxen (group N) in 61 patients who underwent arthroscopic meniscus surgery.

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Baskent University School of Medicine Adana Teaching and Research Hospital, Adana 01250, Turkey
Additional Information

Starting date: January 2013
Last updated: September 26, 2013

Page last updated: August 23, 2015

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