Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Remifentanil and Atropine for Intubation in Neonates (RAIN)

This study has been completed.
Sponsor:
Collaborator:
McMaster University
Information provided by:
King Saud University
ClinicalTrials.gov Identifier:
NCT00815048
First received: December 24, 2008
Last updated: December 26, 2008
Last verified: December 2008

December 24, 2008
December 26, 2008
January 2006
February 2008   (final data collection date for primary outcome measure)
Time to Successful intubation [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00815048 on ClinicalTrials.gov Archive Site
  • Time to return of spontaneous respirations [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Oxygen saturation [ Time Frame: During the procedure up to 15 minutes ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: During the procedure up to 15 minutes ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: During the procedure up to 15 minutes ] [ Designated as safety issue: Yes ]
  • Intubation Condition [ Time Frame: 15 minutes post procedure ] [ Designated as safety issue: No ]
  • Evidence of Trauma [ Time Frame: 15 minutes post procedure ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00815048
RAIN
Yes
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