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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atropine, fentanyl and succinylcholine | Active Comparator | 20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV. |
|
| placebo, fentanyl and succinylcholine | Placebo Comparator | an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atropine | Drug | Atropine 0.02 mg/kg IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate less than 80 BPM and oxygen saturation less than 80% | Heart rate and transcutaneous oxygen saturation will be monitored continuously during the procedure and data will be recorded at 3 stages;
| 5-6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate < 100 BPM | 5-6 minutes | |
| Oxygen saturation < 85% | 5-6 minutes | |
| Duration of intubation attempts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael R Narvey, MD | Contact | 2047872720 | mnarvey@hsc.mb.ca | |
| Jehier Afifi, MD | Contact | 9024706944 | Jehier.afifi@iwk.nshealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael R Narvey, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre | Recruiting | Winnipeg | Manitoba | R3A1R9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40645282 | Derived | Afifi J, El-Naggar W, Hatfield T, Sandila N, Baier J, Narvey M. Atropine Versus Placebo for Neonatal Nonemergent Intubation: A Randomized Clinical Trial. J Pediatr. 2025 Nov;286:114719. doi: 10.1016/j.jpeds.2025.114719. Epub 2025 Jul 9. |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Placebo | Drug | an equivalent volume of normal saline to atropine IV |
|
|
| 1-2 minutes |
| Number of intubation attempts | 5-6 minutes |
| Lowest heart rate after premedication | 5-6 minutes |
| Lowest oxygen saturation after premedication | 5-6 minutes |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |