Intravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02602197
• Other study ID #: KA 13/100
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 31, 2015
• Last updated: November 10, 2015
• Start date: August 2013
• Est. completion date: February 2016

Study information

• Verified date: November 2015
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Paracetamol
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.
• Dexketoprofen
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from pain scores until 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.	Yes
Secondary	Cumulative tramadol consumption during postoperative 24 hours.	Cumulative tramadol consumption was recorded during postoperative 24 hours.	First postoperative 24 hours	Yes