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

Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.

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.

Study Overview

• Status: Completed
• Conditions: Tonsillitis
• Intervention / Treatment: Drug: Fentanyl; Drug: Fentanyl; Drug: Dexmedetomidine; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Fentanyl 1; Fentanyl 1 micrograms (mcg)/kilogram (kg)	Drug: Fentanyl; Fentanyl 1mcg/kg, Intravenous (IV); Other Names: Actiq; Drug: Fentanyl; Fentanyl 2mcg/kg, Intravenous (IV); Other Names: Actiq
ACTIVE_COMPARATOR: Fentanyl 2; Fentanyl 2 micrograms (mcg)/kilogram (kg)	Drug: Fentanyl; Fentanyl 1mcg/kg, Intravenous (IV); Other Names: Actiq; Drug: Fentanyl; Fentanyl 2mcg/kg, Intravenous (IV); Other Names: Actiq
EXPERIMENTAL: Dex 3; Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)	Drug: Dexmedetomidine; Dexmedetomidine, 2mcg/kg, Intravenous (IV); Other Names: Precedex; Drug: Dexmedetomidine; Dexmedetomidine, 4mcg/kg Intravenous (IV); Other Names: Precedex
EXPERIMENTAL: Dex 4; Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)	Drug: Dexmedetomidine; Dexmedetomidine, 2mcg/kg, Intravenous (IV); Other Names: Precedex; Drug: Dexmedetomidine; Dexmedetomidine, 4mcg/kg Intravenous (IV); Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's National Research Institute
• Collaborators: Hospira, now a wholly owned subsidiary of Pfizer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (ACTUAL): October 1, 2008
• Study Completion (ACTUAL): October 1, 2008

Study Registration Dates

• First Submitted: April 3, 2008
• First Submitted That Met QC Criteria: April 7, 2008
• First Posted (ESTIMATE): April 8, 2008

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: tonsillectomy; Dexmedetomidine,; fentanyl,; and adenoidectomy,
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Tonsillitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: 3502; Agreement #10698