Anxiety, Pain
Conditions
Keywords
Neonates
Brief summary
Lumbar puncture is one of the most common painful procedures performed on neonates in the Emergency Department (ED). The investigators will study in a randomized controlled trial, the efficacy of intravenous administration of a single dose of Midazolam in reducing pain and anxiety in neonates undergoing lumbar puncture in the ED, as well as the rate of adverse sedation reactions. The investigators hypothesize that compared with placebo, single dose Midazolam would significantly decrease pain and anxiety and will have low rate of adverse reactions.
Interventions
DRUGMidazolam
Intravenous infusion of 0.05 mg/kg of Midalolam
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Days to 30 Days
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) score I, II * Post natal age ≤ 30 days * Fasting of at least 2 hours before the procedure
Exclusion criteria
* American Society of Anesthesiologists (ASA) score III or greater * Gestational age of 37 weeks or younger * Congenital disease or defect * Any medication provided by the caregiver prior ED admission * Fasting of less than 2 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Simplified Neonatal Facial Coding System will be used for assessment of pain. Scoring will be composed from four specific facial actions (brow bulge, nasolabial furrow, eye squeeze, and open mouth) and the presence or absence of crying | 20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion |
Secondary
| Measure | Time frame |
|---|---|
| Physician's level of satisfaction from the procedural conditions | Five minutes post successful LP |
| LP Success rate | Five minutes post successful LP |
| Adverse sedation reactions | During procedure and during recovery phase |
Countries
Israel
Outcome results
None listed