Abstract

Intranasal dexmedetomidine (IND) is an emerging agent for procedural distress in children. To explore the effectiveness of IND for procedural distress in children. We performed electronic searches of Medline (1946-2019), Embase (1980-2019), Google Scholar (2019), Cumulative Index to Nursing and Allied Health Literature (1981-2019), and Cochrane Central Register. We included randomized trials of IND for procedures in children. Methodologic quality of evidence was evaluated by using the Cochrane Collaboration's risk of bias tool and the Grading of Recommendations Assessment, Development, and Evaluation system, respectively. The primary outcome was the proportion of participants with adequate sedation. Among 19 trials (N = 2137), IND was superior to oral chloral hydrate (3 trials), oral midazolam (1 trial), intranasal midazolam (1 trial), and oral dexmedetomidine (1 trial). IND was equivalent to oral chloral hydrate (2 trials), intranasal midazolam (2 trials), and intranasal ketamine (3 trials). IND was inferior to oral ketamine and a combination of IND plus oral ketamine (1 trial). Higher doses of IND were superior to lower doses (4 trials). Adverse effects were reported in 67 of 727 (9.2%) participants in the IND versus 98 of 591 (16.6%) in the comparator group. There were no reports of adverse events requiring resuscitative measures. The adequacy of sedation was subjective, which possibly led to biased outcome reporting. Given the methodologic limitations of included trials, IND is likely more effective at sedating children compared to oral chloral hydrate and oral midazolam. However, this must be weighed against the potential for adverse cardiovascular effects.

Highlights

  • Among 19 trials (N = 2137), intranasal dexmedetomidine (IND) was superior to oral chloral hydrate (3 trials), oral midazolam (1 trial), intranasal midazolam (1 trial), and oral dexmedetomidine (1 trial)

  • IND was studied for the following nonpainful procedures: ophthalmic examination (3 trials),[23,24,25] transthoracic echocardiography (TTE) (2 trials),[26,27] auditory brainstem response (ABR) testing (2 trials),[28,29] computed tomography (CT) (3 trials)[29,30,31] and MRI (2 trials),[32,33] and visually evoked potentials (VEPs) (1 trial).[29]

  • IND was compared to oral dexmedetomidine,[41] chloral hydrate,[23,26,28,30,33] IND plus oral ketamine,[37] intranasal or oral midazolam,[31,34,39,40] and intranasal or oral ketamine.[35,36,37,40]

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Summary

Methods

We included all published and unpublished randomized trials comparing IND as monotherapy to any comparator for a procedure in children ,19 years and reported adequacy of sedation. Trials of both adults and children were included if the authors provided pediatricspecific data. The primary outcome was the proportion of participants deemed to be adequately sedated on the basis of the investigators’ opinion. We believed this to be the most pragmatic, relevant, and feasible approach to describing relief of procedural distress. Secondary outcomes included the need for additional sedation, onset and duration of sedation, length of stay, analgesia, adverse events, and acceptance of intranasal administration

Results
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