Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

University of Manitoba

Status and phase: Unknown; Phase 4

Conditions: Bradycardia; Hypoxemia

Treatments: Drug: atropine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01595399

R500458

Details and patient eligibility

About

The purpose of this study is to compare heart rate in infants who receive atropine as a part of their medication before intubation to those who do not.

To be able to find out , we need to divided babies into 2 groups;

group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline ( placebo group) + sedation + muscle relaxant

Then we need to compare heart rate during intubation and duration of intubation between the 2 groups.

Full description

We hypothesize that premedication for intubation with fentanyl and succinylcholine alone will maintain equal stability of heart rate and oxygen saturation without a prolongation of time to completion of intubation when compared to a protocol using atropine, fentanyl and succinylcholine.

In order to answer this question we plan to undertake a prospective randomized double blinded control trial of use of atropine as an adjunct for elective intubation of infants less than 46 weeks postmenstrual age.

Enrollment: 70 estimated patients

Sex: All

Ages: 1 day to 2 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation.
• IV access is obtained
• Informed parental consent

Exclusion criteria

• Emergent intubation or need for resuscitation
• Congenital cyanotic heart disease
• Obvious airway abnormalities
• History of myopathy or family history of malignant hyperthermia or known history of phosphocholinesterase deficiency

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Atropine, fentanyl and succinylcholine

Active Comparator group

Description:

20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.

Treatment:

Drug: atropine

placebo, fentanyl and succinylcholine

Placebo Comparator group

Description:

an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.

Treatment:

Drug: Placebo