Naproxen Codeine in Arthroscopic Surgery

Phase 4

Completed

• Conditions: Arthroscopic Meniscus Surgery

• Registration Number: NCT01952652
• Lead Sponsor: Baskent University

Brief 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.

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2013-09
• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-26
• Last Update Submitted: 2013-09-26
• Study First Posted: 2013-09-30
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	postoperative 18 hours	patients will be followed postoperatively 18 hours for pain levels

Trial Locations

Locations (1)

Baskent University School of Medicine Adana Teaching and Research Hospital; 🇹🇷 Adana, Turkey