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Naproxen Codeine in Arthroscopic Surgery

B

Baskent University

Status and phase

Completed
Phase 4

Conditions

Arthroscopic Meniscus Surgery

Treatments

Drug: Group N:Naproxen sodium
Drug: Group NC :naproxen sodium codeine phosphate

Study type

Interventional

Funder types

Other

Identifiers

NCT01952652
KA12/268

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

61 participants in 2 patient groups

Group Naproxen sodium (Group N)
Active Comparator group
Description:
Group N received naproxen sodium 550 mg 60 minutes before surgery.
Treatment:
Drug: Group N:Naproxen sodium
Group Naproxen sodium codeine phosphate (Group NC)
Active Comparator group
Description:
Group NC received naproxen sodium 550 mg+30 mg codeine 60 minutes before surgery.
Treatment:
Drug: Group NC :naproxen sodium codeine phosphate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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