Back to resultsParacetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia
Primary Purpose
Other Acute Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paracetamol
Dipyrone
Sponsored by
About this trial
This is an interventional treatment trial for Other Acute Postoperative Pain focused on measuring Pediatric spinal anesthesia, paracetamol, dipyrone
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Paracetamol
Dipyrone
Arm Description
15 mg/kg paracetamol, IV (in the vein)(premixed with 0.9% sodium chloride to a total of 50 ml)single dose
15 mg/kg IV (in the vein)dipyrone received (premixed with 0.9% sodium chloride to a total of 50 ml), single dose
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01858402
Brief Title
Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Acute Postoperative Pain
Keywords
Pediatric spinal anesthesia, paracetamol, dipyrone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
15 mg/kg paracetamol, IV (in the vein)(premixed with 0.9% sodium chloride to a total of 50 ml)single dose
Arm Title
Dipyrone
Arm Type
Active Comparator
Arm Description
15 mg/kg IV (in the vein)dipyrone received (premixed with 0.9% sodium chloride to a total of 50 ml), single dose
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Parol
Intervention Description
15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose
Intervention Type
Drug
Intervention Name(s)
Dipyrone
Other Intervention Name(s)
Metamizole
Intervention Description
15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose
Primary Outcome Measure Information:
Title
Change from pain intensity until postoperative 6 hours
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.
Time Frame
Pain intensity recorded until postoperative 6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
24144215
Citation
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.
Results Reference
derived
Learn more about this trial
Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia
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