Condition category
Surgery
Date applied
19/10/2004
Date assigned
19/10/2004
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

McMaster University (Canada)

Sponsor details

Division of Newborn Medicine
1200 Main Street West
Hamilton
ON
L8S 4J9
Canada

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15461825

Publication citations

  1. 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.

Additional files

Editorial Notes