Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy

Tonsillitis Clinical Trial

— DexT&A  

Official title:

Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654511
• Other study ID #: 3502
• Secondary ID: Agreement #10698
• Status: Completed
• Phase: Phase 4
• Start date: January 2005
• Est. completion date: October 2008

Study information

• Verified date: March 2021
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Tonsillitis

Intervention

Drug:
• Fentanyl
Fentanyl 1mcg/kg, Intravenous (IV)
• Fentanyl
Fentanyl 2mcg/kg, Intravenous (IV)
• Dexmedetomidine
Dexmedetomidine, 2mcg/kg, Intravenous (IV)
• Dexmedetomidine
Dexmedetomidine, 4mcg/kg Intravenous (IV)

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Children's National Research Institute	Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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