Skip to main content
Clinical Trials/NCT01858402
NCT01858402
Completed
Phase 2

The Efficacy of Intravenous Paracetamol Versus Dipyrone for Postoperative Analgesia After Day-case Lower Abdominal Surgery in Children With Spinal Anesthesia: a Prospective Randomized Double-blind Study

Baskent University0 sites2 target enrollmentDecember 2009

Overview

Phase
Phase 2
Intervention
Paracetamol
Conditions
Other Acute Postoperative Pain
Sponsor
Baskent University
Enrollment
2
Primary Endpoint
Change from pain intensity until postoperative 6 hours
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.

Detailed Description

The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
July 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Esra Caliskan

Associated Professor

Baskent University

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologist (ASA) physical status I and II children undergoing elective lower abdominal surgery

Exclusion Criteria

  • increased intracranial pressure hemorrhagic diathesis infection at the puncture site Those with a known history of allergy to the study drugs

Arms & Interventions

Paracetamol

15 mg/kg paracetamol, IV (in the vein)(premixed with 0.9% sodium chloride to a total of 50 ml)single dose

Intervention: Paracetamol

Dipyrone

15 mg/kg IV (in the vein)dipyrone received (premixed with 0.9% sodium chloride to a total of 50 ml), single dose

Intervention: Dipyrone

Outcomes

Primary Outcomes

Change from pain intensity until postoperative 6 hours

Time Frame: Pain intensity recorded until postoperative 6 hours

The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.

Similar Trials