Postoperative Analgesia in Children After Propofol Anesthesia (propan)

The investigators hypothesize that patients anesthetized with sevoflurane have more pain, postoperatively, than those anesthetized with propofol.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Antigona Hasani, MD, MSC; Phone Number: +37744402781; Email: antigona.hasani@gmail.com
• Study Contact Backup: Name: Antiogna Hasani; Phone Number: 3015 +38138500600

Study Locations

• Serbia
  • Kosovo
    • Pristina, Kosovo, Serbia, 10000
      • Recruiting
      • University Clinical Center of Kosovo
      • Contact: Antigona Hasani, MD,MSC; Phone Number: 3015 +38138500600; Email: antigona.hasani@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: drug: propofol; 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: Propofol; 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.; Other Names: Diprivan; Sevorane
Active Comparator: Sevoflurane group:sevoflurane; 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.	Drug: Propofol; 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.; Other Names: Diprivan; Sevorane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery time	Recovery time, defined as the time until eye opening on command or the time of first response to command after anesthesia	120 minutes
adverse effects	Adverse effects during the surgery and after recovery: hypotension, bradicardia, intense coughing, hypersalivation and laryngospasm, nausea, and vomiting.	0-120 minutes

Collaborators and Investigators

• Sponsor: University Clinical Centre of Kosova
• Investigators: Principal Investigator: Antigona Hasani, MD,MSC, University Clinical Centre of Kosova

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: April 20, 2011
• First Submitted That Met QC Criteria: April 26, 2011
• First Posted (Estimate): April 27, 2011

Study Record Updates

• Last Update Posted (Estimate): April 27, 2011
• Last Update Submitted That Met QC Criteria: April 26, 2011
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: sevoflurane; children; propofol; postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: UCCK-55; RAA12 (Registry Identifier: RAA12)