Premedication for intubation in neonates: a randomised controlled trial

ISRCTN	ISRCTN43546373
DOI	https://doi.org/10.1186/ISRCTN43546373
Protocol serial number	N/A
Sponsor	McMaster University (Canada)
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Brigitte Lemyre
Scientific

CHEO, Dept of Pediatrics
401, Smyth Road
Ottawa
K1H 8L1
Canada

Phone	+1 613 737 8561
Email	blemyre@ottawahospital.on.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PIN
Study objectives	Elective endotracheal intubations are still commonly performed without premedication in many institutions. The hypothesis tested in this study was that morphine given prior to elective intubations in neonates would decrease fluctuations in vital signs, shorten the duration of intubation and reduce the number of attempts.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Endotracheal intubation in neonates
Intervention	Morphine 0.2 mg/kg IV compared to placebo 5 minutes before an endotracheal intubation
Intervention type	Procedure/Surgery
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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).
Completion date	30/09/2000

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	34
Key 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.
Key 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.
Date of first enrolment	01/12/1999
Date of final enrolment	30/09/2000

CHEO, Dept of Pediatrics

Ottawa
K1H 8L1
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/10/2004		Yes	No