None listed
Conditions
Brief summary
Ill newborns frequently need breathing tubes inserted into their trachea in order to help with their breathing. This can cause pain and adverse physiological responses, such as changes in blood pressure, which may be harmful to the infant. We routinely give these infants medications beforehand, to lessen the impact the procedure has on them. The best drug or drug combination in infants is not known. In our neonatal unit, we use a combination of Morphine and Midazolam, which may not be ideal, as it takes long to work. We aim to compare these 2 drugs with a single agent, Propofol, an anaesthetic agent, used in theatres to insert breathing tubes. We do not know which of these drugs are better, that is why we have started this study. The study is expected to run for 18 months.
Interventions
Propofol in a dose of 3mg/kg as an intravenous bolus dose. A maximum of 2 doses will be allowed.
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
28 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
All infants > 28 weeks' gestation, with parental consent, in the neonatal unit, who need elective or semi-elective endotracheal intubation.
Exclusion criteria
No parental consent. Infants with major congenital abnormalities. Infants with cyanotic congenital heart lesions, incl. infants with duct-dependant circulation. Infants with hypotension. Infants with hypovolemia. Infants with hypoxic ischaemic encephalopathy. Infants who are deemed septic. Infants with suspected or proven metabolic diseases. Infants with a family history of metabolic disease. Infants with pulmonary hypertension
Outcome results
None listed