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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01858402
Enrollment
2
Registered
2013-05-21
Start date
2009-12-31
Completion date
2011-07-31
Last updated
2013-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Acute Postoperative Pain

Keywords

Pediatric spinal anesthesia, paracetamol, dipyrone

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.

Interventions

DRUGParacetamol

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

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

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from pain intensity until postoperative 6 hoursPain intensity recorded until postoperative 6 hoursThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026