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Postoperative Analgesia in Children After Propofol Anesthesia (propan)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University Clinical Centre of Kosova.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Clinical Centre of Kosova
ClinicalTrials.gov Identifier:
NCT01342835
First received: April 20, 2011
Last updated: April 26, 2011
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Postoperative Pain
Drug: Propofol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia in Children After Propofol Anesthesia

Resource links provided by NLM:


Further study details as provided by University Clinical Centre of Kosova:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    The Faces Pain Scale (FPS) (from five face drawings: 0 = no pain, 5 = extreme pain) is used to assess pain severity


Secondary Outcome Measures:
  • recovery time [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Recovery time, defined as the time until eye opening on command or the time of first response to command after anesthesia

  • adverse effects [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]
    Adverse effects during the surgery and after recovery: hypotension, bradicardia, intense coughing, hypersalivation and laryngospasm, nausea, and vomiting.


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Antigona Hasani, UCCK
ClinicalTrials.gov Identifier: NCT01342835     History of Changes
Other Study ID Numbers: UCCK-55, RAA12
Study First Received: April 20, 2011
Last Updated: April 26, 2011
Health Authority: Kosovo: Medical Faculty Ethical Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Anesthetics
Propofol
Sevoflurane
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014