Children commonly present to ED with injuries requiring procedures that can be painful or
require a child to be absolutely still. Pain in young children has been universally
under-recognized due to their inability to describe or localize pain. Multiple surveys of
parents and families have showed that ED satisfaction is highly dependent on the degree
of pain a patient experiences and the efforts made to alleviate the pain. Therefore,
improvements in pharmacological interventions are necessary to optimize patient and
family experience and allow for successful and efficient procedure completion.
Intranasal Midazolam is widely used for minimal procedural anxiolysis in pediatric
population. Intranasal medication delivery has the highest parent and provider
satisfaction with the advantage of avoiding painful needle stick and faster absorption
compared to oral or intramuscular medication. Midazolam is a gamma-aminobutyric acid
(GABA) receptor agonist that can provide anxiolysis and amnesia but no analgesia.
Intranasal Midazolam has a rapid onset of 5-10 minutes with peak at 30 minutes. There
have been limited studies evaluating the length of stay or time to discharge after
medication administration with an average length of stay of about 30 minutes. It has been
shown to be safe and effective in children for minor procedures; however, intranasal
Midazolam is notoriously noxious and irritating to nasal mucosa and requires larger
volumes for intranasal dosing. Main side effects include respiratory depression and
hypotension. It is also known to cause paradoxical reaction with hyperactivity,
agitation, and restlessness especially in developmentally delayed or children with Autism
or behavioral concerns. Therefore, several new studies have evaluated other newer
intranasal medications for minor procedures including intranasal Dexmedetomidine and
intranasal Ketamine.
Dexmedetomidine is an alpha 2 agonist that mirrors sleep in children and can provide
anxiolysis and minimal analgesia. Intranasal dosages that have provided adequate minimal
sedation is 2-4mcg/kg (max dosage 100-200mcg) with wide range of onset 10-45 mins with
average 30 minutes and peak at 90 minutes. Unlike Midazolam, it preserves airway reflexes
without clinically significant hemodynamic instability in children. Studies have also
shown that it is well tolerated by children and preferred in children with Autism and
behavioral concerns.
Ketamine is an N-methyl-D-aspartate (NMDA) antagonist that provides both anxiolysis and
analgesia. It is widely used in ED settings for intravenous procedural sedation; however,
intranasal route provides non-invasive method of medication administration. Gutherie et
al conducted a study demonstrating intranasal Ketamine providing safe and successful
anxiolysis and analgesia in pediatric patients in an ED setting. Intranasal dosage of
3-5mg/kg (max dosage 100-200mg) provides optimal onset of action within 10 minutes with
peak at 15-20 minutes and duration of 45-60 minutes. It has few significant side effects
including the rare laryngospasm and recovery agitation, however, it preserves airway
reflexes and favorable in hemodynamic instability.
Previous Studies:
Limited studies have demonstrated anxiolysis with patient and provider satisfaction or
time to discharge after medication administration comparing intranasal Midazolam to
intranasal Dexmedetomidine or intranasal Ketamine in a pediatric emergency medicine
setting. Neville et al conducted a study comparing intranasal Dexmedetomidine and
intranasal Midazolam prior to laceration repair in a pediatric emergency department and
concluded that patients who received Dexmedetomidine had less anxiety at the time of
positioning for the procedure. Several other studies have demonstrated similar outcomes
with better patient and provider satisfaction in pre-operative settings, imaging, and
dental settings. Surendar et al is the only study that compared all three intranasal
medications. The study included uncooperative pediatric patients in a dental setting.
Although overall differences were not statistically significant, the onset of sedation
was rapid among Intranasal Ketamine and Midazolam groups but overall success was highest
in Dexmedetomidine group.
Objective/Aims/Hypothesis:
This is the first study that will compare all three intranasal medications to evaluate
the length of stay after medication administration along with patient and provider
satisfaction. The objective of this study is to demonstrate superior intranasal
anxiolysis for pediatric laceration repairs with the shortest emergency department stay
and highest patient and provider satisfaction. The primary outcome will measure the time
to discharge after medication administration. Other measurements with include patient's
anxiety using previously validated scale Modified Yale Preoperative Anxiety Scale (mYPAS)
and physician and parent satisfaction using 5 point Likert scale. Based on previous
studies and medication pharmacokinetics, we hypothesize that Ketamine will have the
shortest ED stay followed by Midazolam and then Dexmedetomidine with the longest stay;
however, Dexmedetomidine will have the highest patient and provider satisfaction followed
by Ketamine and then Midazolam.