NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial.
Niklas BreindahlTine Brink HenriksenChristian HeiringEmma Therese BayJannie HaaberTenna Gladbo SalmonsenEmma Louise Malchau CarlsenGitte ZachariassenPeter AgergaardAnne-Cathrine Finnemann ViuffLars BenderMartin Grønnebæk TolsgaardLise AunsholtPublished in: Pediatric research (2024)
Pre-procedure analgesia is associated with apnoea and may complicate procedures that rely on regular spontaneous breathing, such as Less Invasive Surfactant Administration (LISA). This randomised controlled trial addresses the effect of analgesic premedication in LISA by comparing fentanyl with a placebo (isotonic saline) in infants undergoing the LISA procedure. All infants will receive standardised non-pharmacological comfort. The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort or pain in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice regarding analgesic treatment associated with the LISA procedure.
Keyphrases
- preterm infants
- study protocol
- phase iii
- clinical practice
- neuropathic pain
- minimally invasive
- clinical trial
- randomized controlled trial
- pain management
- chronic pain
- anti inflammatory
- spinal cord
- intensive care unit
- risk assessment
- obstructive sleep apnea
- combination therapy
- postoperative pain
- positive airway pressure
- double blind