Naproxen Codeine in Arthroscopic Surgery

Study Overview
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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.

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

Conditions
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Arthroscopic Meniscus Surgery

Intervention / Treatment
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* Drug: Group N:Naproxen sodium
* Drug: Group NC :naproxen sodium codeine phosphate


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Naproxen sodium (Group N)<br>Group N received naproxen sodium 550 mg 60 minutes before surgery. | Drug: Group N:Naproxen sodium<br>* drug will be given 60 minutes before surgery<br>* Other names: Apranax fort tb, Abdi Ibrahim Ilaç,Turkiye;|
| Active Comparator: Group Naproxen sodium codeine phosphate (Group NC)<br>Group NC received naproxen sodium 550 mg+30 mg codeine 60 minutes before surgery. | Drug: Group NC :naproxen sodium codeine phosphate<br>* drug will be given 60 minutes before surgery<br>* Other names: Apranax plus tb, Abdi Ibrahim Ilac, Turkey;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | patients will be followed postoperatively 18 hours for pain levels | postoperative 18 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Naproxen-codeine, preemptive analgesia, day case surgery