Postoperative Analgesia in Children After Propofol Anesthesia (propan)

University Clinical Centre of Kosova

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Postoperative Pain

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01342835

RAA12 (Registry Identifier)

UCCK-55

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

drug: propofol

Active Comparator group

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.

Treatment:

Drug: Propofol

Sevoflurane group:sevoflurane

Active Comparator group

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.

Treatment:

Drug: Propofol