Remifentanil and Atropine for Intubation in Neonates (RAIN)

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

Condition Intervention Phase
Endotracheal Intubation
Drug: Atropine/Remifentanil
Drug: Fentanyl/Atropine/Succinylcholine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Remifentanil and Atropine for Intubation in Neonates; a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Time to Successful intubation [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: January 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Remifentanil



Drug: Atropine/Remifentanil

Atropine 20mcg/kg

Remifentanil 3mcg/kg

Placebo Comparator: Fentanyl




Drug: Fentanyl/Atropine/Succinylcholine

Atropine 20mcg/kg

Fentanyl 2mcg/kg

Succinylcholine 2mg/kg


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00815048

Canada, Ontario
McMaster University NICU
Hamilton, Ontario, Canada, L8S 4J9
Sponsors and Collaborators
King Saud University
McMaster University
Principal Investigator: Khalid M Alfaleh, MBBS, MSc King Saud University
Study Director: Karen Choong, FRCPC McMaster University
  More Information

Responsible Party: Khalid AlFaleh, King Saud University Identifier: NCT00815048     History of Changes
Other Study ID Numbers: RAIN 
Study First Received: December 24, 2008
Last Updated: December 26, 2008
Health Authority: Canada: Health Canada

Keywords provided by King Saud University:
Endotracheal intubation
Endotracheal Intubation in Neonates

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Central Nervous System Depressants
Cholinergic Agents
Cholinergic Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neuromuscular Agents
Neuromuscular Blocking Agents
Neuromuscular Depolarizing Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 26, 2016