Remifentanil and Atropine for Intubation in Neonates

Endotracheal Intubation Clinical Trial

— RAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815048
• Other study ID #: RAIN
• Status: Completed
• Phase: Phase 4
• First received: December 24, 2008
• Last updated: December 26, 2008
• Start date: January 2006
• Est. completion date: February 2008

Study information

• Verified date: December 2008
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

Drug:
• Atropine/Remifentanil
Atropine 20mcg/kg Remifentanil 3mcg/kg
• Fentanyl/Atropine/Succinylcholine
Atropine 20mcg/kg Fentanyl 2mcg/kg Succinylcholine 2mg/kg

Locations

Country	Name	City	State
Canada	McMaster University NICU	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
King Saud University	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Successful intubation		15 minutes	No
Secondary	Time to return of spontaneous respirations		15 minutes	No
Secondary	Oxygen saturation		During the procedure up to 15 minutes	Yes
Secondary	Heart Rate		During the procedure up to 15 minutes	Yes
Secondary	Blood Pressure		During the procedure up to 15 minutes	Yes
Secondary	Intubation Condition		15 minutes post procedure	No
Secondary	Evidence of Trauma		15 minutes post procedure	Yes