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Premedication for intubation in neonates: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN43546373
Enrollment
34
Registered
2004-10-19
Start date
1999-12-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Endotracheal intubation in neonates Surgery

Interventions

Morphine 0.2 mg/kg IV compared to placebo 5 minutes before an endotracheal intubation

Sponsors

McMaster University (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Newborn infants of all gestations admitted to one Neonatal Intensive Care Unit. Infants of all gestations, admitted to McMaster University Medical Center level III NICU and considered likely to need an elective oral or nasotracheal intubation during their hospital stay, were candidates for inclusion in this study. Families were approached for consent as soon as possible after birth when an elective intubation during their hospital stay seemed likely: if their infant(s) was less than 30 weeks gestation, already ventilated (as endotracheal tubes are frequently changed after 10 days if clinical deterioration from a respiratory standpoint), was on NCPAP for respiratory distress or was needing an elective surgery. Others were approached when an elective intubation was needed. At the time of this study, our unit was a 33-bed level 3 NICU, caring for both inborn and outborn patients, and the referral center for 25000 annual deliveries, with 900-1000 admissions per year.

Exclusion criteria

Exclusion criteria: 1. Absence of an intravenous access 2. Upper airway anomaly potentially leading to a difficult intubation 3. Cyanotic heart disease 4. Upper gastrointestinal obstruction (which would require a rapid sequence intubation) 5. Concurrent opioid administration.

Design outcomes

Primary

MeasureTime frame
The study aimed to test the hypothesis that morphine 0.2 mg/kg would decrease fluctuations in vital signs, shorten the duration of the procedure and reduce the number of attempts. The primary outcome was the duration of severe hypoxemia, defined as Sp02 < 85% with a HR< 90/min. This was felt to be the most undesirable side effect of endotracheal intubation as cerebral blood flow in neonates is highly dependent upon heart rate.

Secondary

MeasureTime frame
1. Duration of the procedure 2. Duration of hypoxemia (Sp02 < 85%) 3. Number of attempts 4. Maximum change in blood pressure from baseline 5. Occurrence of bradycardia (HR<90/min).

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026