Postoperative Analgesia in Children After Propofol Anesthesia

Phase 1

• Conditions: Postoperative Pain
• Interventions: Drug: Propofol

• Registration Number: NCT01342835
• Lead Sponsor: University Clinical Centre of Kosova

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.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Primary Completion: 2011-01
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-26
• Last Update Submitted: 2011-04-26
• Study First Posted: 2011-04-27
• Last Update Posted: 2011-04-27
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug: propofol	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.
Sevoflurane group:sevoflurane	Propofol	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.

Primary Outcome Measures

Name	Time	Method
postoperative pain	120 minutes	The Faces Pain Scale (FPS) (from five face drawings: 0 = no pain, 5 = extreme pain) is used to assess pain severity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Clinical Center of Kosovo; 🇷🇸 Pristina, Kosovo, Serbia