Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Fentanyl 1

Fentanyl 1 micrograms (mcg)/kilogram (kg)

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Fentanyl 1mcg/kg, Intravenous (IV)

Fentanyl 2

Fentanyl 2 micrograms (mcg)/kilogram (kg)

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Fentanyl 2mcg/kg, Intravenous (IV)

Dex 3

Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine, 2mcg/kg, Intravenous (IV)

Dex 4

Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine, 4mcg/kg Intravenous (IV)

Interventions

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Fentanyl

Fentanyl 1mcg/kg, Intravenous (IV)

Intervention Type DRUG

Fentanyl

Fentanyl 2mcg/kg, Intravenous (IV)

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine, 2mcg/kg, Intravenous (IV)

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine, 4mcg/kg Intravenous (IV)

Intervention Type DRUG

Other Intervention Names

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Actiq Actiq Precedex Precedex

Eligibility Criteria

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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

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).

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes