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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
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Atropine

Remifentanil

Drug: Atropine/Remifentanil

Atropine 20mcg/kg

Remifentanil 3mcg/kg

Placebo Comparator: Fentanyl

Atropine

Fentanyl

Succinylcholine

Drug: Fentanyl/Atropine/Succinylcholine

Atropine 20mcg/kg

Fentanyl 2mcg/kg

Succinylcholine 2mg/kg


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815048


Locations
Canada, Ontario
McMaster University NICU
Hamilton, Ontario, Canada, L8S 4J9
Sponsors and Collaborators
King Saud University
McMaster University
Investigators
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
ClinicalTrials.gov Identifier: NCT00815048     History of Changes
Other Study ID Numbers: RAIN
First Submitted: December 24, 2008
First Posted: December 29, 2008
Last Update Posted: December 29, 2008
Last Verified: December 2008

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

Additional relevant MeSH terms:
Fentanyl
Remifentanil
Atropine
Succinylcholine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents