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Postoperative Analgesia in Children After Propofol Anesthesia (propan)

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 1
Locations
Serbia
Study Type
Interventional
Intervention
Propofol
Sponsored by
University Clinical Centre of Kosova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring propofol, sevoflurane, postoperative pain, children

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • allergy to any of the drugs
  • preoperative anxiety
  • postoperative agitation
  • ASA physical status >II

Sites / Locations

  • University Clinical Center of KosovoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

drug: propofol

Sevoflurane group:sevoflurane

Arm Description

Drug: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.

Drug: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.

Outcomes

Primary Outcome Measures

postoperative pain
The Faces Pain Scale (FPS) (from five face drawings: 0 = no pain, 5 = extreme pain) is used to assess pain severity

Secondary Outcome Measures

recovery time
Recovery time, defined as the time until eye opening on command or the time of first response to command after anesthesia
adverse effects
Adverse effects during the surgery and after recovery: hypotension, bradicardia, intense coughing, hypersalivation and laryngospasm, nausea, and vomiting.

Full Information

First Posted
April 20, 2011
Last Updated
April 26, 2011
Sponsor
University Clinical Centre of Kosova
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1. Study Identification

Unique Protocol Identification Number
NCT01342835
Brief Title
Postoperative Analgesia in Children After Propofol Anesthesia
Acronym
propan
Official Title
Postoperative Analgesia in Children After Propofol Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Clinical Centre of Kosova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesize that patients anesthetized with sevoflurane have more pain, postoperatively, than those anesthetized with propofol.
Detailed Description
In a randomize, prospective, double-blind study, the subjects are 100 premedicated children, aged 3 to 6 years, who undergo one type of surgical procedure, hernia repair surgery. Anesthesia is maintains with propofol anesthesia (group P, n=50) or with sevoflurane anesthesia (group S, n=50). and fentanyl administered during surgery. Faces Pain Scale (FPS) is use to assess pain severity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
propofol, sevoflurane, postoperative pain, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
drug: propofol
Arm Type
Active Comparator
Arm Description
Drug: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.
Arm Title
Sevoflurane group:sevoflurane
Arm Type
Active Comparator
Arm Description
Drug: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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan, Sevorane
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative pain
Description
The Faces Pain Scale (FPS) (from five face drawings: 0 = no pain, 5 = extreme pain) is used to assess pain severity
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
recovery time
Description
Recovery time, defined as the time until eye opening on command or the time of first response to command after anesthesia
Time Frame
120 minutes
Title
adverse effects
Description
Adverse effects during the surgery and after recovery: hypotension, bradicardia, intense coughing, hypersalivation and laryngospasm, nausea, and vomiting.
Time Frame
0-120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: allergy to any of the drugs preoperative anxiety postoperative agitation ASA physical status >II
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antigona Hasani, MD, MSC
Phone
+37744402781
Email
antigona.hasani@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Antiogna Hasani
Phone
+38138500600
Ext
3015
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antigona Hasani, MD,MSC
Organizational Affiliation
University Clinical Centre of Kosova
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinical Center of Kosovo
City
Pristina
State/Province
Kosovo
ZIP/Postal Code
10000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antigona Hasani, MD,MSC
Phone
+38138500600
Ext
3015
Email
antigona.hasani@gmail.com

12. IPD Sharing Statement

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Postoperative Analgesia in Children After Propofol Anesthesia

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