• 
• 

Three Part Question

In [children requiring procedural sedation] is [intranasal dexmedetomidate compared to other intranasal sedatives] a [practical drug to consider using to provide safe and effective sedation] within the emergency department.

Clinical Scenario

A 7 year old boy is brought to the emergency department (ED) after falling onto the corner of a table. On examination he is noted to have a large laceration across his right cheek that needs suturing. The young boy is afraid of needles and will not allow you to place a cannula or give an IM injection. As the ED physician, you consider using intranasal dexmedetomidine for sedation in this patient.

Search Strategy

Medline 1966-04/16 using OVID interface, Cochrane Library (2016), and Embase


[(exp intranasal dexmedetomidine/) AND (exp child/ or "children".mp. or exp pediatrics/ or "pediatric". mp]. Limit to clinical trials and English

Search Outcome

26 studies were identified; five randomized clinical trials (RCTs) addressed the clinical question.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Gyanesh P, et al. June 2013 India	150 children ages 1-10 years old randomized into three groups dexmedetomidate (DXM) at 1 ug/kg + saline, ketamine at 5mg/kg + saline, saline + saline.	RCT	Most children tolerated the intranasal drugs with minimal discomfort. 90.4% of anesthesiologists in the DXM group and 82.7% in the ketamine group were satisfied with the sedation, only 21.3% of providers were satisfied with saline alone. Parents were satisfied 97.3% of the time with DXM and 92.4% of the time with ketamine compared to 41.6% with the control group. DXM and K groups required less propofol, had better quality MRIs and the children had earlier awakenings than saline only.	Intranasal DXM and ketamine were equally effective as premedication for IV cannulation in children undergoing MRI.	Primary outcome was IV cannulation, in the ER this can be done with lidocaine jets in a painless manner. This study looked at quality of MRIs, a non-painful procedure, often in the emergency setting, sedation is required for painful procedures. DXM has a long onset of action, which may not be feasible in a busy ER or MRI suite. This study required a second intranasal drug for blinding purposes. Study used tuberculin syringes for IN administration as opposed to newer methods such as atomized.
Sheta SA, et al. September 2013 Saudi Arabia	72 children aged 3-6 years old with ASA class I and II undergoing complete dental rehabilitation were randomized to intranasal DXM at 0.1 ug/mg or midazolam 0.2 mg/kg.	RCT	There was a quicker onset of action in the midazolam group (10-25 min) when compared to the DXM group (20-40 min). Patients given DXM (77.8%) were more sedated than the midazolam group (44.4%). Secondary outcomes includes mask application compliance 58.3% vs. 80.6% for midazolam and DXM, respectively. Postoperative agitation were lower in the DXM group compared to midazolam. All patients were hemodynamically stable.	Intrasnasal DXM is an effective and safe alternative for premedication in children with superior sedation when compared to intranasal midazolam.	Did not use an atomizer to administer IN drugs. DXM long onset of action.
Surendar N, et al. March 2014 India	84 children ages 4-14 years old with an ASA class I, who were uncooperative during dental procedure and could not be redirected. Patients were randomized to four groups: DXM at 1 ug/mg, DXM at 1.5 ug/mg, midazolam at 0.2 mg/kg and ketamine at 5mg/kg via the intranasal route.	RCT	Midazolam and ketamine have quicker onset of actions when compared to the DXM doses. Success rates were highest in the higher dose DXM (85.7%) followed by lower dose DXM (81%), then ketamine (66.7%), then midazolam 61.9%), but this finding was not statistically significant. Heart rate and systolic blood pressures decreased significantly in the DXM groups compared to the ketamine and midazolam, but were still within normal physiologic parameters. DXM and ketamine produced greater intra- and post-operative analgesia compared to midazolam.	DXM, midazolam and ketamine can be used safely and effectively through the intranasal route in uncooperative pediatric dental patients for producing moderate sedation.	Did not use an atomizer to administer IN drugs. DXM long onset of action.
Dewhirst E, et al. July 2014 USA	100 children aged 1 to 7.7 years old undergoing bilateral myringotomy and tympanostomy tube placement were equally randomized to (1) oral midazolam + IN DXM at 1 ug/kg, (2) oral midazolam + IN fentanyl at 2 ug/kg, (3) IN DXM at 1 ug/kg and (4) IN fentanyl at 2 ug/kg. All patients were given rectal Tylenol at 40 mg/kg. IN medications were given after the induction of anesthesia with sevoflurane.	RCT	Pain scores were comparable in groups 2, 3 and 4. Group 1 (midazolam and IN DXM) had a significantly higher post operative pain score. No statistically significant total time in PACU or to hospital discharge between the 4 groups. Group 3 (IN DXM) had significantly lower heart rates throughout the procedure and in the PACU. Blood pressures were stable among all 4 groups.	Following bilateral myringotomy and tympanostomy tube placement, when no premedication is administered, there was no clinical advantage when comparing IN DXM to IN fentanyl. The addition of oral midazolam as a premedication worsened the outcome measures particulary for children receiving IN DXM.	Given intraop rather than preop. Given the delayed onset of action and delayed peak plasma times, DXM is unlikely to be at full effect in the immediate postop period when pain score were taken in the PACU after a short procedure.

Comment(s)

As procedural sedation becomes more prevalent in the emergency department, especially in children, new and safer sedative agents are sought. Intranasal administration of sedatives is fast acting, effective, well tolerated, and may avoid the need for securing venous access in children. Dexmedetomidine is a potent, highly selective, and specific adrenoreceptor agonist that has both sedative and analgesic effects.

Clinical Bottom Line

Dexmedetomidate presents an effective option for intransal procedural sedation. It compares favorably to intranasal fentanyl, midazolam, and ketamine

References

1. Talon MD, et al. Intranasal Dexmedetomidine Premedication is Comparable with Midazolam in Burn Children Undergoing Reconstructive Surgery Journal of Burn Care & Research 2009 Jul-Aug; 30(4):599-605
2. Gyanesh P, et al. Comparison between intranasal dexmedetomidine and intranasal ketamine as premedication for procedural sedation in children undergoing MRI: a double-blind, randomized, placebo-controlled trial. Journal of Anesthesia 2014 Feb; 28(1):12-8
3. Sheta SA, et al. Intranasal Demedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial Paediatric Anaesthesia 2014 Feb; 24(2):181-9
4. Surendar N, et al. A Comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind randomized study The Journal of Clinical Pediatric Denistry 2014 Spring; 38(3): 255-61
5. Dewhirst E, et al. Pain management following myringotomy and tube placement: intranasal dexmedetomidine versus intranasal fentanyl International Journal of Pediatric Otorhinolaryngology 2014 July; 78(7): 1090-4