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Completed

NCT Number: NCT00815048

Remifentanil and Atropine for Intubation in Neonates

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.

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Key information

Conditions

Endotracheal Intubation

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McMaster University NICU

Hamilton, Ontario, L8S 4J9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine/Remifentanil

Drug

Atropine 20mcg/kg

Remifentanil 3mcg/kg

Fentanyl/Atropine/Succinylcholine

Drug

Atropine 20mcg/kg

Fentanyl 2mcg/kg

Succinylcholine 2mg/kg

Primary outcomes

  1. Time to Successful intubation

    Time frame: 15 minutes

Secondary outcomes

  1. Time to return of spontaneous respirations

    Time frame: 15 minutes

  2. Oxygen saturation

    Time frame: During the procedure up to 15 minutes

  3. Heart Rate

    Time frame: During the procedure up to 15 minutes

  4. Blood Pressure

    Time frame: During the procedure up to 15 minutes

  5. Intubation Condition

    Time frame: 15 minutes post procedure

  6. Evidence of Trauma

    Time frame: 15 minutes post procedure

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Collaborators

  • McMaster University

Registry information

Official study title

Remifentanil and Atropine for Intubation in Neonates; a Randomized Controlled Trial

Acronym: RAIN

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 29, 2008
Registry last updated
Dec 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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