Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain on Postoperative Pain

Diskapi Yildirim Beyazit Training and Research Hospital

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain, PCA Contramal Consumption

Treatments: Drug: Placebo; Drug: paracetamol codein; Drug: naproxen sodium codein

Study type: Interventional

Funder types: Other

Identifiers

NCT02252614

DiskapiYBERH

Details and patient eligibility

About

Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour after a lumbar disk surgery.

Full description

Patients were treated using patient-controlled analgesia with contramal for 24 hours after a lumbar disk surgery and randomized to receive IV naproksen sodium+codein, paracetamol+codein or isotonic saline (placebo).

The primary endpoint was pain intensity measured by the visual analogue scale, and secondary endpoints were contramal consumption and related side effects.

Enrollment: 75 estimated patients

Sex: All

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists 1 or 2 status patients scheduled for elective lumbar disk surgery under general anesthesia

Exclusion criteria

• Patients, known allergies to any of the drugs used in this study
• eptic ulcer disease, hepatic and renal dysfunction, emergency surgery, or inability to provide informed consent (eg, mental disorders)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

Naproxen sodium codein

Active Comparator group

Description:

Preoperative Naproxen sodium codein administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.

Treatment:

Drug: naproxen sodium codein

Paracetamol codein

Experimental group

Description:

Preoperative paracetamol codein administrered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.

Treatment:

Drug: paracetamol codein

Placebo tablet

Placebo Comparator group

Description:

Preoperative placebo tablet administered, pain intensity measured by the visual analogue scale, and contramal consumption and related side effects evaluated.

Treatment:

Drug: Placebo