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Remifentanil and Atropine for Intubation in Neonates (RAIN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815048
First Posted: December 29, 2008
Last Update Posted: December 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
McMaster University
Information provided by:
King Saud University
December 24, 2008
December 29, 2008
December 29, 2008
January 2006
February 2008   (Final data collection date for primary outcome measure)
Time to Successful intubation [ Time Frame: 15 minutes ]
Same as current
No Changes Posted
  • Time to return of spontaneous respirations [ Time Frame: 15 minutes ]
  • Oxygen saturation [ Time Frame: During the procedure up to 15 minutes ]
  • Heart Rate [ Time Frame: During the procedure up to 15 minutes ]
  • Blood Pressure [ Time Frame: During the procedure up to 15 minutes ]
  • Intubation Condition [ Time Frame: 15 minutes post procedure ]
  • Evidence of Trauma [ Time Frame: 15 minutes post procedure ]
Same as current
Not Provided
Not Provided
 
Remifentanil and Atropine for Intubation in Neonates
Remifentanil and Atropine for Intubation in Neonates; a Randomized Controlled Trial
The investigators hypothesize that the use of a combination of Atropine and Remifentanil will safely facilitate non emergent intubation procedure as effectively as the protocol of Atropine, Fentanyl, and Succinylcholine.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Endotracheal Intubation
  • Drug: Atropine/Remifentanil

    Atropine 20mcg/kg

    Remifentanil 3mcg/kg

  • Drug: Fentanyl/Atropine/Succinylcholine

    Atropine 20mcg/kg

    Fentanyl 2mcg/kg

    Succinylcholine 2mg/kg

  • Active Comparator: Remifentanil

    Atropine

    Remifentanil

    Intervention: Drug: Atropine/Remifentanil
  • Placebo Comparator: Fentanyl

    Atropine

    Fentanyl

    Succinylcholine

    Intervention: Drug: Fentanyl/Atropine/Succinylcholine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hemodynamically stable neonates of any gestational age admitted to the Neonatal Intensive Care Unit at McMaster Children's Hospital requiring an elective endotracheal intubation was anticipated.

Exclusion Criteria:

  • Urgent intubations
  • Cyanotic congenital heart lesions
  • Anticipated difficult airway
  • Concurrent or recently administered (within 3 hours of the procedure) intravenous opioid infusions
  • Pre-existing hyperkalemia
  • Family history of malignant hyperthermia
  • Prior enrollment
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00815048
RAIN
Yes
Not Provided
Not Provided
Khalid AlFaleh, King Saud University
King Saud University
McMaster University
Principal Investigator: Khalid M Alfaleh, MBBS, MSc King Saud University
Study Director: Karen Choong, FRCPC McMaster University
King Saud University
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP