PREMIX vs PREMED Intranasal Lidocaine and Midazolam
Status:
Completed
Trial end date:
2017-10-10
Target enrollment:
Participant gender:
Summary
Intranasal (IN) midazolam is an anxiolytic that is commonly used in the pediatric population
for procedural anxiolysis in the emergency department (ED) setting to facilitate painful and
distressing procedures, such as laceration repairs. Intranasal midazolam is both effective
and safe in children. However, due to the acidic nature of midazolam, there is a burning
sensation that is associated with the intranasal administration of midazolam. The use of IN
lidocaine has been shown to decrease the pain associated with the administration of IN
midazolam and other acidic solutions. The IN lidocaine can be given as a premedication
(PREMED), where it is sprayed in the nares first to provide topical anesthesia, and then
followed by the administration of the IN midazolam. Lidocaine can also be given concurrently
with the IN midazolam (PREMIX), where it is mixed with the midazolam and then the combined
mixture administered. Both methods have been shown to be effective in decreasing the pain
associated with the intranasal administration of acidic solutions, such as midazolam,
although the PREMIX method could have the advantage of requiring less number of sprays, and
be tolerated better by children. Although both methods have been shown to work, it is not
known if the PREMIX method is non-inferior to the PREMED method for decreasing pain and
distress associated with administering IN midazolam. Therefore, the investigators aim to
determine if the PREMIX method is non-inferior to the PREMED method of using lidocaine to
decrease the pain and distress associated with the administration of IN midazolam in
children.