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Completed

NCT Number: NCT00654511

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.

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All of the following criteria must be met for the potential subject to be eligible for participation:
  • The subject is 2 to 12 years of age
  • The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).
  • The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).
  • The subject will be hospitalized overnight after surgery
  • 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:
  • The subject has a history or a family (parent or sibling) history of malignant hyperthermia
  • The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests.
  • The subject has a known or suspected allergy to opioid analgesics
  • 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.
  • 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).

Treatment and study plan

Fentanyl

Drug

Fentanyl 1mcg/kg, Intravenous (IV)

Other names: Actiq

Dexmedetomidine

Drug

Dexmedetomidine, 2mcg/kg, Intravenous (IV)

Other names: Precedex

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Official study title

Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.

Acronym: DexT&A

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 8, 2008
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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