|
Main
|
|
Note: This record shows only the 20 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:
|
17 October 2012 |
|
Main ID: |
NCT00468052 |
|
Date of registration:
|
27/04/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy
|
|
Scientific title:
|
Use of Dexmedetomidine Infusion for Analgesia and Emergence Agitation for Children Undergoing Tonsillectomy and Adenotonsillectomy |
|
Date of first enrolment:
|
March 2007 |
|
Target sample size:
|
122 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00468052 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Anuradha Patel, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Medicne & Dentistry of New Jersey |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- ages 2-10 ASA rating of I-III undergoing general anesthesia tonsillectomy with and
without adenoidectomy
Exclusion Criteria:
- diagnosis of anxiety disorder or chronic pain syndrome chronic disabilities or
developmental delays are currently on psychotherapeutic or sedating medication are on
chronic pain medication or opiate any known adverse effect to the study drug any
known cardiac abnormalities
Age minimum:
2 Years
Age maximum:
10 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Obstructive Sleep Apnea
|
|
Intervention(s)
|
|
Drug: dexmedetomidine
|
|
Drug: fentanyl
|
|
Primary Outcome(s)
|
|
Pain and emergent agitation tool
[Time Frame: 2 hours postoperatively]
|
|
time to awakening
[Time Frame: following end of anesthetic medication]
|
|
time to extubation
[Time Frame: after awakening]
|
|
vital signs (Heart rate, blood pressure, oxygen sat,respiratory rate, end title carbon dioxide, BIS)at five minute intervals perioperatively
[Time Frame: 5 minute intervals postoperatively]
|
|
Secondary Outcome(s)
|
|
Objective Pain Scale and use of rescue medication
[Time Frame: 2 hours postoperatively]
|
|
Pediatric Anesthesia Emergence Delirium
[Time Frame: 2 hours postoperatively]
|
|
Post operative Emesis
[Time Frame: 2 hours postoperatively]
|
|
Secondary ID(s)
|
|
0120060313
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|