Intravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty

Phase 3

• Conditions: Postoperative Pain
• Interventions: Drug: Paracetamol; Drug: Dexketoprofen

• Registration Number: NCT02602197
• Lead Sponsor: Baskent University

Brief Summary

The investigators conducted a prospective, randomized, double blind study to compare the effectiveness of intravenous paracetamol and dexketoprofen for preventing pain during first 24 hours postoperative period in adult patient undergoing septoplasty.

Detailed Description

Postoperative pain scores as measured by Visual Analog Scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60 minutes and 2th, 4th, 6th, 12th and 24th hours postoperatively.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-03-31
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-10
• Last Update Submitted: 2015-11-10
• Study First Posted: 2015-11-11
• Last Update Posted: 2015-11-11
• Primary Completion: 2015-12
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• After patient's inform consent was approved, a total of 70 ASA (American Society of Anesthesiology) physical status I and II adult patients age 18 to 65 undergoing septoplasty were planned include the study.

Exclusion Criteria

• History of clotting disorders or blood dyscrasias,
• Gastrointestinal ulcer or chronic dyspepsia,
• History of allergy to the study drugs,
• Active bleeding or bleeding disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracetamol	Paracetamol	1 gr paracetamol received intravenously bolus 15 minutes after anesthetic induction and at the postoperative 6 th,12 th, 18 th and 24 th hours
Dexketoprofen	Dexketoprofen	50 mg dexketoprofen received intravenous bolus 15 minutes after anesthetic induction and at the postoperative 8 th,16 th and 24 th hours.

Primary Outcome Measures

Name	Time	Method
Change from pain scores until postoperative 24 hours	Pain scores recorded during postoperative 24 hours.	Pain scores as measured by Visual Analog Scale (VAS) at 15 and 30 minutes, 1h, 2h, 4h, 6h, 12h, and 24 h after surgery

Secondary Outcome Measures

Name	Time	Method
Cumulative tramadol consumption during postoperative 24 hours.	First postoperative 24 hours	Cumulative tramadol consumption was recorded during postoperative 24 hours.