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

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.

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Key information

Conditions

Other Acute Postoperative Pain

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

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

Other names: Parol

dipyrone

Drug

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

Other names: Metamizole

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.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: May 21, 2013
Registry last updated: May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed