Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy (DexT&A)

Study Description

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Brief Summary:

The primary purpose of this study is:

1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia.
2. To determine an analgesic dose response relationship for dexmedetomidine.
3. Compare recovery characteristics of dexmedetomidine to fentanyl.

Condition or disease	Intervention/treatment	Phase
Tonsillitis	Drug: Fentanyl; Drug: Dexmedetomidine	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	101 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.
Study Start Date :	January 2005
Actual Primary Completion Date :	October 2008
Actual Study Completion Date :	October 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Fentanyl 1; Fentanyl 1 micrograms (mcg)/kilogram (kg)	Drug: Fentanyl; Fentanyl 1mcg/kg, Intravenous (IV); Other Name: Actiq
Active Comparator: Fentanyl 2; Fentanyl 2 micrograms (mcg)/kilogram (kg)	Drug: Fentanyl; Fentanyl 2mcg/kg, Intravenous (IV); Other Name: Actiq
Experimental: Dex 3; Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)	Drug: Dexmedetomidine; Dexmedetomidine, 2mcg/kg, Intravenous (IV); Other Name: Precedex
Experimental: Dex 4; Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)	Drug: Dexmedetomidine; Dexmedetomidine, 4mcg/kg Intravenous (IV); Other Name: Precedex

Outcome Measures

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Primary Outcome Measures :

1. Time to First Morphine Dose [ Time Frame: up to 24 hours ]
   Total minutes from study medication administration to time of first morphine dose.
2. Morphine Rescue [ Time Frame: up to 24 hours ]
   Total morphine administered in the Post Anesthesia Care Unit (PACU)

Eligibility Criteria

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Ages Eligible for Study:	2 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• All of the following criteria must be met for the potential subject to be eligible for participation:

  1. The subject is 2 to 12 years of age
  2. The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).
  3. The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).
  4. The subject will be hospitalized overnight after surgery

  5. The subject's parent/legally authorized guardian has given written informed consent to participate; and where applicable, the subject has given appropriate assent to participate.

     Exclusion Criteria:

• The potential subject is NOT eligible for participation if any of the following exclusion criteria apply:

  1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
  2. The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests.
  3. The subject has a known or suspected allergy to opioid analgesics
  4. The subject is a pregnant or lactating female (if post-menarcheal, a negative pregnancy test must be confirmed prior to the planned surgery time (in AMSAC) consistent with current standard of care.
  5. The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhthymias, conditions where hypotension is to be avoided).

Contacts and Locations

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Locations

United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010

Sponsors and Collaborators

Children's Research Institute

Hospira, now a wholly owned subsidiary of Pfizer

Investigators

Principal Investigator:	Julia C Finkel, MD	Children's Research Institute

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2.

Responsible Party:	Julia C. Finkel, MD, Children's National Medical Center
ClinicalTrials.gov Identifier:	NCT00654511 History of Changes
Other Study ID Numbers:	3502; Agreement #10698
First Posted:	April 8, 2008
Results First Posted:	April 26, 2011
Last Update Posted:	April 26, 2011
Last Verified:	March 2011

Keywords provided by Children's Research Institute:

Dexmedetomidine,; fentanyl,; tonsillectomy; and adenoidectomy,

Additional relevant MeSH terms:

Tonsillitis; Pharyngitis; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Dexmedetomidine; Fentanyl; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics	Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics