Postoperative Analgesia in Children After Propofol Anesthesia
propan
2 other identifiers
interventional
100
1 country
1
Brief Summary
The investigators hypothesize that patients anesthetized with sevoflurane have more pain, postoperatively, than those anesthetized with propofol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 postoperative-pain
Started Sep 2010
1 active site
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
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 20, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedApril 27, 2011
September 1, 2010
4 months
April 20, 2011
April 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative pain
The Faces Pain Scale (FPS) (from five face drawings: 0 = no pain, 5 = extreme pain) is used to assess pain severity
120 minutes
Secondary Outcomes (2)
recovery time
120 minutes
adverse effects
0-120 minutes
Study Arms (2)
drug: propofol
ACTIVE COMPARATORDrug:Propofol and sevoflurane The induction dose of propofol is 3-5 mg/kg-1 (mean induction dose: 4 mg/kg-1) follow by propofol infusion (12 mg/kg/h-1 for the first 10 min of general anesthesia, 9 mg/kg/h-1 for another 10 min, and 6 mg/kg/h-1 thereafter; mean maintenance dose: 9 mg/kg/h-1) and a 50:50 mixture of N2O and O2.
Sevoflurane group:sevoflurane
ACTIVE COMPARATORDrug:Sevoflurane and Propofol Mask induction is perform with sevoflurane (4-6%) follow by 1.5-2% sevoflurane in a 50:50 mixture of N2O and O2.
Interventions
The induction dose of propofol is 3-5 mg/kg-1 (mean induction dose: 4 mg/kg-1) follow by propofol infusion (12 mg/kg/h-1 for the first 10 min of general anesthesia, 9 mg/kg/h-1 for another 10 min, and 6 mg/kg/h-1 thereafter; mean maintenance dose: 9 mg/kg/h-1) and a 50:50 mixture of N2O and O2.
Eligibility Criteria
You may qualify if:
- Patient is 3- 6 years old
- Patient is scheduled for hernia repair surgery at University Clinical center of Kosovo Patients is ASA I/II Patient meets criteria to receive either propofol or sevoflurane anesthesia Patient's parent/guardian provides written consent
You may not qualify if:
- allergy to any of the drugs
- preoperative anxiety
- postoperative agitation
- ASA physical status \>II
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinical Center of Kosovo
Pristina, Kosovo, 10000, Serbia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antigona Hasani, MD,MSC
University Clinical Centre of Kosova
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 20, 2011
First Posted
April 27, 2011
Study Start
September 1, 2010
Primary Completion
January 1, 2011
Study Completion
July 1, 2011
Last Updated
April 27, 2011
Record last verified: 2010-09