Intravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty

November 10, 2015 updated by: Esra Caliskan, Baskent University

The Efficacy of Intravenous Paracetamol Versus Dexketoprofen for Postoperative Pain Management After Septoplasty: A Prospective Randomized Double Blind Study

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.

Study Overview

Status

Unknown

Conditions

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
After anesthetic induction, the first I.V bolus injections of 1 gr paracetamol (total amount of 100 ml) were given during 15 minutes and then repeated every 6 h until 24 h postoperative period.
Other Names:
  • Parol
Active Comparator: Dexketoprofen
50 mg dexketoprofen received intravenous bolus 15 minutes after anesthetic induction and at the postoperative 8 th,16 th and 24 th hours.
After anesthetic induction, the first I.V bolus injections of 50 mg Dexketoprofen (premixed with 0.9 % sodium chloride to total amount of 100 ml) were given during 15 minutes and then repeated every 8 h until 24 h postoperative period.
Other Names:
  • Arveles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from pain scores until postoperative 24 hours
Time Frame: 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
Pain scores recorded during postoperative 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative tramadol consumption during postoperative 24 hours.
Time Frame: First postoperative 24 hours
Cumulative tramadol consumption was recorded during postoperative 24 hours.
First postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

November 11, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Paracetamol

Subscribe