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
Recruitment status was Recruiting
Sponsor:
University Clinical Centre of Kosova
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
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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:
|
|
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:
|
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
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 Postoperative Complications Pathologic Processes Pain Signs and Symptoms Anesthetics Propofol Sevoflurane Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation |
ClinicalTrials.gov processed this record on June 18, 2013