Overview

This trial is active, not recruiting.

Condition postoperative pain
Treatments paracetamol, dexketoprofen
Phase phase 3
Sponsor Baskent University
Start date August 2013
End date December 2015
Trial size 2 participants
Trial identifier NCT02602197, KA 13/100

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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
paracetamol Parol
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.
(Active Comparator)
50 mg dexketoprofen received intravenous bolus 15 minutes after anesthetic induction and at the postoperative 8 th,16 th and 24 th hours.
dexketoprofen Arveles
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.

Primary Outcomes

Measure
Change from pain scores until postoperative 24 hours
time frame: Pain scores recorded during postoperative 24 hours.

Secondary Outcomes

Measure
Cumulative tramadol consumption during postoperative 24 hours.
time frame: First postoperative 24 hours

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title The Efficacy of Intravenous Paracetamol Versus Dexketoprofen for Postoperative Pain Management After Septoplasty: A Prospective Randomized Double Blind Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Baskent University.