Premedication for intubation in neonates: a randomised controlled trial
| ISRCTN | ISRCTN43546373 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43546373 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/10/2004
- Registration date
- 19/10/2004
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Brigitte Lemyre
Scientific
Scientific
CHEO, Dept of Pediatrics
401, Smyth Road
Ottawa
K1H 8L1
Canada
| Phone | +1 613 737 8561 |
|---|---|
| blemyre@ottawahospital.on.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| 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 | 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 study start date | 01/12/1999 |
| Completion date | 30/09/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Canada
Study participating centre
CHEO, Dept of Pediatrics
Ottawa
K1H 8L1
Canada
K1H 8L1
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
Division of Newborn Medicine
1200 Main Street West
Hamilton, ON
L8S 4J9
Canada
"ROR" |
https://ror.org/02fa3aq29 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/10/2004 | Yes | No |
