Status:
COMPLETED
Decrease Emergence Agitation and Provide Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
2-10 years
Phase:
PHASE3
Brief Summary
Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery carried out in children who very often also present with obstructive sleep apnea. To provide pain relief, i.e. an...
Detailed Description
Emergence agitation (EA) from general anesthesia is a frequent phenomenon in children age 1-10 yrs recovering from anesthesia that demands increasing nursing care in the PACU, delays reunion with pare...
Eligibility Criteria
Inclusion
- ages 2-10 ASA rating of I-III undergoing general anesthesia tonsillectomy with and without adenoidectomy
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00468052
Start Date
March 1 2007
End Date
May 1 2008
Last Update
December 5 2016
Active Locations (1)
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1
UMDNJ University Hospital
Newark, New Jersey, United States, 07103