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OpenTrials
Completed

NCT Number: NCT01952652

Naproxen Codeine in Arthroscopic Surgery

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.

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Key information

Conditions

Arthroscopic Meniscus Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baskent University School of Medicine Adana Teaching and Research Hospital

Adana, 01250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group N:Naproxen sodium

Drug

drug will be given 60 minutes before surgery

Other names: Apranax fort tb, Abdi Ibrahim Ilaç,Turkiye

Group NC :naproxen sodium codeine phosphate

Drug

drug will be given 60 minutes before surgery

Other names: Apranax plus tb, Abdi Ibrahim Ilac, Turkey

Primary outcomes

  1. 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.

    Time frame: postoperative 18 hours

    patients will be followed postoperatively 18 hours for pain levels

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 30, 2013
Registry last updated
Sep 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.