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Remifentanil and Atropine for Intubation in Neonates

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00815048
Acronym
RAIN
Enrollment
30
Registered
2008-12-29
Start date
2006-01-31
Completion date
2008-02-29
Last updated
2008-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation

Keywords

Remifentanil, Endotracheal intubation, Premedication, Sedation, Endotracheal Intubation in Neonates

Brief summary

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.

Interventions

DRUGAtropine/Remifentanil

Atropine 20mcg/kg Remifentanil 3mcg/kg

DRUGFentanyl/Atropine/Succinylcholine

Atropine 20mcg/kg Fentanyl 2mcg/kg Succinylcholine 2mg/kg

Sponsors

McMaster University
CollaboratorOTHER
King Saud University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Time to Successful intubation15 minutes

Secondary

MeasureTime frame
Oxygen saturationDuring the procedure up to 15 minutes
Heart RateDuring the procedure up to 15 minutes
Time to return of spontaneous respirations15 minutes
Intubation Condition15 minutes post procedure
Evidence of Trauma15 minutes post procedure
Blood PressureDuring the procedure up to 15 minutes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026