Contact information
Type
Scientific
Primary contact
Dr Brigitte Lemyre
ORCID ID
Contact details
CHEO
Dept of Pediatrics
401
Smyth Road
Ottawa
K1H 8L1
Canada
+1 613 737 8561
blemyre@ottawahospital.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PIN
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Endotracheal intubation in neonates
Intervention
Morphine 0.2 mg/kg IV compared to placebo 5 minutes before an endotracheal intubation
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
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).
Overall trial start date
01/12/1999
Overall trial end date
30/09/2000
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
34
Participant 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.
Recruitment start date
01/12/1999
Recruitment end date
30/09/2000
Locations
Countries of recruitment
Canada
Trial participating centre
CHEO, Dept of Pediatrics
Ottawa
K1H 8L1
Canada
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15461825
Publication citations
-
Results
Lemyre B, Doucette J, Kalyn A, Gray S, Marrin ML, Morphine for elective endotracheal intubation in neonates: a randomized trial [ISRCTN43546373]., BMC Pediatr, 2004, 4, 20, doi: 10.1186/1471-2431-4-20.