Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy - Full Text View

Sponsored by:	University of Medicine and Dentistry New Jersey
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00468052

Purpose

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. analgesia, current practice relies on opioids , e.g., morphine or fentanyl. These narcotics are known to depress respiration and to increase the incidence of post-operative nausea and vomiting. These side effects are worrisome in this patient cohort. An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high safety profile in adults as well as in sedation in children. The purpose of this study is to determine if intravenous dexmedetomidine given as an infusion during general anesthesia for tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following surgery.

Condition	Intervention	Phase
Obstructive Sleep Apnea	Drug: dexmedetomidine Drug: fentanyl	Phase III

MedlinePlus related topics: Anesthesia Nausea and Vomiting Sleep Apnea Tonsils and Adenoids

Drug Information available for: Fentanyl Citrate Fentanyl Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Use of Dexmedetomidine Infusion for Analgesia and Emergence Agitation for Children Undergoing Tonsillectomy and Adenotonsillectomy

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
time to awakening [ Time Frame: following end of anesthetic medication ] [ Designated as safety issue: Yes ]
time to extubation [ Time Frame: after awakening ] [ Designated as safety issue: Yes ]
Pain and emergent agitation tool [ Time Frame: 2 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective Pain Scale and use of rescue medication [ Time Frame: 2 hours postoperatively ] [ Designated as safety issue: Yes ]
Pediatric Anesthesia Emergence Delirium [ Time Frame: 2 hours postoperatively ] [ Designated as safety issue: Yes ]
Post operative Emesis [ Time Frame: 2 hours postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion

1 microgram/kilogram as a bolus

Show Detailed Description

Eligibility

Ages Eligible for Study:	2 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468052

Contacts

Contact: Catherine E. Schoenberg, RN	973 972-7477	shoenbce@umdnj.edu
Contact: Henry L. Bennett, PhD	973 972-6623	bennethl@umdnj.edu

Locations

United States, New Jersey
UMDNJ University Hospital	Recruiting
Newark, New Jersey, United States, 07103
Contact: Catherine E. Schoenberg 973-972-7477 shoenbce@umdnj.edu
Contact: Kimberly Y. Louis 973 972-6623 louisky@umdnj.edu
Principal Investigator: Anuradha Patel, MD

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Investigators

Principal Investigator:

Anuradha Patel, MD

University of Medicne & Dentistry of New Jersey

More Information

Publications:

Isik B, Arslan M, Tunga AD, Kurtipek O. Dexmedetomidine decreases emergence agitation in pediatric patients after sevoflurane anesthesia without surgery. Paediatr Anaesth. 2006 Jul;16(7):748-53. Erratum in: Paediatr Anaesth. 2006 Jul;16(7):811.

Responsible Party:	UMDNJ ( Anuradha Patel, MD )
Study ID Numbers:	0120060313
Study First Received:	April 27, 2007
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00468052
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:

obstructive sleep apnea
tonsillectomy
adenoidectomy

Study placed in the following topic categories:

Fentanyl
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Apnea, Obstructive

Dyssomnias
Sleep Disorders
Pain
Psychomotor Agitation
Dexmedetomidine
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions

Adrenergic Agonists
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009