Infant, Newborn, Pain
Conditions
Keywords
pain, analgesia, morphine, amethocaine, neonate
Brief summary
This study will test which type of pain medication is best for the management of pain in newborn preterm and full-term infants having a deep intravenous cannula inserted. It will compare the effectiveness of intravenous morphine alone, a local anaesthetic cream (amethocaine) alone, and both medications together. It will also determine the safety of both medications.
Interventions
DRUGmorphine, amethocaine
Sponsors
Canadian Society of Hospital Pharmacists
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
Inclusion criteria
* preterm and full-term infants in the NICU requiring a percutaneous central venous catheter * ventilatory support in the form of conventional ventilation, Continuous Positive Air Pressure (CPAP) or High Frequency Oscillation(HFO)
Exclusion criteria
* seizures * receiving muscle relaxants * skin disorders causing disruption of stratum corneum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Facial grimacing, as assessed by brow bulge, at the time of the procedure, compared among groups | — |
Secondary
| Measure | Time frame |
|---|---|
| heart rate at the time of procedure | — |
| oxygen saturation at the time of procedure | — |
| local skin reactions at the time of procedure | — |
| blood pressure for 24 hours post procedure | — |
| ventilatory support for 24 hours post procedure | — |
Countries
Canada
Outcome results
None listed