Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT01342835 |
Date of registration:
|
20/04/2011 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Postoperative Analgesia in Children After Propofol Anesthesia
propan |
Scientific title:
|
Postoperative Analgesia in Children After Propofol Anesthesia |
Date of first enrolment:
|
September 2010 |
Target sample size:
|
100 |
Recruitment status: |
Recruiting |
URL:
|
http://clinicaltrials.gov/show/NCT01342835 |
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
|
Phase:
|
Phase 1/Phase 2
|
|
Countries of recruitment
|
Serbia
| | | | | | | |
Contacts
|
Name:
|
Antigona Hasani, MD,MSC |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
University Clinical Centre of Kosova |
|
Name:
|
Antigona Hasani, MD, MSC |
Address:
|
|
Telephone:
|
+37744402781 |
Email:
|
antigona.hasani@gmail.com |
Affiliation:
|
|
|
Name:
|
Antigona Hasani, MD,MSC |
Address:
|
|
Telephone:
|
+38138500600 |
Email:
|
antigona.hasani@gmail.com |
Affiliation:
|
|
|
Key inclusion & exclusion 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
Age minimum:
3 Years
Age maximum:
6 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Postoperative Pain
|
Intervention(s)
|
Drug: Propofol
|
Primary Outcome(s)
|
postoperative pain
[Time Frame: 120 minutes]
|
Secondary Outcome(s)
|
adverse effects
[Time Frame: 0-120 minutes]
|
recovery time
[Time Frame: 120 minutes]
|
Secondary ID(s)
|
UCCK-55
|
RAA12
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|