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Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy

NCT00654511 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2021-03-23

Study results available
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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.

Conditions

  • Tonsillitis

Interventions

DRUG

Fentanyl

Fentanyl 1mcg/kg, Intravenous (IV)

DRUG

Fentanyl

Fentanyl 2mcg/kg, Intravenous (IV)

DRUG

Dexmedetomidine

Dexmedetomidine, 2mcg/kg, Intravenous (IV)

DRUG

Dexmedetomidine

Dexmedetomidine, 4mcg/kg Intravenous (IV)

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Julia C Finkel, MD · Children's National Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00654511 on ClinicalTrials.gov