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
1 other identifier
interventional
2
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 16, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedMay 21, 2013
May 1, 2013
1.2 years
May 16, 2013
May 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Paracetamol
ACTIVE COMPARATOR15 mg/kg paracetamol, IV (in the vein)(premixed with 0.9% sodium chloride to a total of 50 ml)single dose
Dipyrone
ACTIVE COMPARATOR15 mg/kg IV (in the vein)dipyrone received (premixed with 0.9% sodium chloride to a total of 50 ml), single dose
Interventions
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
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologist (ASA) physical status I and II children undergoing elective lower abdominal surgery
You may not qualify if:
- increased intracranial pressure hemorrhagic diathesis infection at the puncture site Those with a known history of allergy to the study drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Caliskan E, Sener M, Kocum A, Ozyilkan NB, Ezer SS, Aribogan A. 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 placebo-controlled study. BMC Anesthesiol. 2013 Oct 22;13(1):34. doi: 10.1186/1471-2253-13-34.
PMID: 24144215DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
May 16, 2013
First Posted
May 21, 2013
Study Start
December 1, 2009
Primary Completion
March 1, 2011
Study Completion
July 1, 2011
Last Updated
May 21, 2013
Record last verified: 2013-05