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Postoperative Analgesia in Children After Propofol Anesthesia (propan)

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ClinicalTrials.gov Identifier: NCT01342835
Recruitment Status : Unknown
Verified September 2010 by University Clinical Centre of Kosova.
Recruitment status was:  Recruiting
First Posted : April 27, 2011
Last Update Posted : April 27, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The investigators hypothesize that patients anesthetized with sevoflurane have more pain, postoperatively, than those anesthetized with propofol.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Propofol Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia in Children After Propofol Anesthesia
Study Start Date : September 2010
Primary Completion Date : January 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. postoperative pain [ Time Frame: 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 :
  1. recovery time [ Time Frame: 120 minutes ]
    Recovery time, defined as the time until eye opening on command or the time of first response to command after anesthesia

  2. adverse effects [ Time Frame: 0-120 minutes ]
    Adverse effects during the surgery and after recovery: hypotension, bradicardia, intense coughing, hypersalivation and laryngospasm, nausea, and vomiting.


Eligibility Criteria

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342835


Contacts
Contact: Antigona Hasani, MD, MSC +37744402781 antigona.hasani@gmail.com
Contact: Antiogna Hasani +38138500600 ext 3015

Locations
Serbia
University Clinical Center of Kosovo Recruiting
Pristina, Kosovo, Serbia, 10000
Contact: Antigona Hasani, MD,MSC    +38138500600 ext 3015    antigona.hasani@gmail.com   
Sponsors and Collaborators
University Clinical Centre of Kosova
Investigators
Principal Investigator: Antigona Hasani, MD,MSC University Clinical Centre of Kosova
More Information

Responsible Party: Antigona Hasani, UCCK
ClinicalTrials.gov Identifier: NCT01342835     History of Changes
Other Study ID Numbers: UCCK-55
RAA12 ( Registry Identifier: RAA12 )
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: April 27, 2011
Last Verified: September 2010

Keywords provided by University Clinical Centre of Kosova:
propofol
sevoflurane
postoperative pain
children

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation