Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia

Other Acute Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858402
• Other study ID #: KA 09/06
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2013
• Last updated: May 20, 2013
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: May 2013
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Other Acute Postoperative Pain
• Pain, Postoperative

Intervention

Drug:
• Paracetamol
15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose
• Dipyrone
15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose

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 intensity 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.	Pain intensity recorded until postoperative 6 hours