Postoperative Analgesia in Children After Propofol Anesthesia

Postoperative Pain Clinical Trial

— propan  

Official title:

Postoperative Analgesia in Children After Propofol Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01342835
• Other study ID #: UCCK-55
• Secondary ID: RAA12
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 20, 2011
• Last updated: April 26, 2011
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2010
• Source: University Clinical Centre of Kosova
• Contact: Antigona Hasani, MD, MSC
• Phone: +37744402781
• Email: antigona.hasani[@]gmail.com
• Is FDA regulated: No
• Health authority: Kosovo: Medical Faculty Ethical BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Serbia	University Clinical Center of Kosovo	Pristina	Kosovo

Sponsors (1)

Lead Sponsor	Collaborator
University Clinical Centre of Kosova

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	adverse effects	Adverse effects during the surgery and after recovery: hypotension, bradicardia, intense coughing, hypersalivation and laryngospasm, nausea, and vomiting.	0-120 minutes	No