Naproxen Codeine in Arthroscopic Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01952652

Enrollment

Registered

2013-09-30

Start date

2013-01-31

Completion date

2013-07-31

Last updated

2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroscopic Meniscus Surgery

Keywords

Naproxen-codeine, preemptive analgesia, day case surgery

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.

Interventions

DRUGGroup N:Naproxen sodium

drug will be given 60 minutes before surgery

DRUGGroup NC :naproxen sodium codeine phosphate

drug will be given 60 minutes before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026