A Phase 2 interventional study of Midazolam in Pain and Anxiety, sponsored by Rambam Health Care Campus. Terminated at 1 site in Israel. Open to participants aged 3 Days to 30 Days. Per ClinicalTrials.gov, last updated 2014-05-06.
Sponsored by Rambam Health Care Campus · Phase 2, Interventional, and Treatment
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.
Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Administration of Midazolam prior Lumbar Puncture
Drug: Midazolam
Intravenous infusion of 0.05 mg/kg of Midalolam
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
Time frame: 20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion
Physician's level of satisfaction from the procedural conditions
Time frame: Five minutes post successful LP
LP Success rate
Time frame: Five minutes post successful LP
Adverse sedation reactions
Time frame: During procedure and during recovery phase
This study is terminated, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Rambam Health Care Campus