Elsevier

Clinical Therapeutics

Volume 38, Issue 6, June 2016, Pages 1522-1529
Clinical Therapeutics

Rescue Sedation With Intranasal Dexmedetomidine for Pediatric Ophthalmic Examination After Chloral Hydrate Failure: A Randomized, Controlled Trial

https://doi.org/10.1016/j.clinthera.2016.04.036Get rights and content

Abstract

Purpose

It is a challenge to rescue ophthalmology examinations performed in children in the sedation room after initial chloral hydrate failure. Intranasal dexmedetomidine can be used in rescue sedation in children undergoing computed tomography. The present study aimed to assess the efficacy and tolerability of intranasal dexmedetomidine use in children undergoing ophthalmic examination after chloral hydrate failure.

Methods

Sixty uncooperative pediatric patients with cataract (aged 5–36 months; weight, 7–15 kg) presented for follow-up ophthalmic examination. Patients who experienced chloral hydrate failure were randomized to 1 of 2 groups to receive intranasal dexmedetomidine 1 or 2 μg/kg for rescue sedation. Each group contained 30 patients. The primary outcome was the rate of a successful ophthalmic examination. Secondary outcomes included sedation onset time, recovery time, duration of examination, discharge time, and adverse events, including percentage of heart rate reduction, respiratory depression, vomiting, and postsedative agitation.

Findings

A successful ophthalmic examination was achieved in 93.3% (28/30) of patients in the 2-μg/kg dose group and in 66.7% (20/30) of patients in the 1-μg/kg dose group (P = 0.021). The onset time, recovery time, and discharge time did not significantly differ between the 2 groups. None of the patients required clinical intervention due to heart rate reduction, and none of the patients in either group experienced vomiting, respiratory depression, or agitation after the administration of dexmedetomidine.

Implications

In children undergoing ophthalmic examination, intranasal dexmedetomidine can be administered in the sedation room for rescue sedation after chloral hydrate failure, with the 2-μg/kg dose being more efficacious than the 1-μg/kg dose, as measured by success rate. ClinicalTrials.gov identifier: NCT02077712.

Introduction

Detailed examinations and diagnostic procedures are necessary for ophthalmologists to appropriately treat pediatric patients with eye diseases.1 Therein, it becomes very important to sedate uncooperative children.2 Chloral hydrate is one of the most commonly used agents for mild to moderate sedation in children who cannot tolerate a painless procedure.3 Chloral hydrate administered by trained nurses has been used for many years for sedation in pediatric ophthalmic examinations, without an accompanying significant risk for respiratory depression.4 Furthermore, a recent large-scale study reported that chloral hydrate was well-tolerated in ophthalmic examinations, with a 92.8% success rate at a dose of 80 mg/kg.5

Maintaining a fixed eye position, with a vertical alignment of the head, on the scanner during ophthalmic examinations is required for obtaining accurate data. However, this special position, which is different from that required for other examinations, may require moderate to deep sedation in children. It should be noted that many children cannot complete the examination even with a maximal dose of chloral hydrate, mostly due to a high prevalence of vomiting and diarrhea and the special examination position required.6, 7, 8 General anesthetic agents such as propofol, fentanyl, midazolam, and ketamine are often ultimately used for rescue sedation in the surgical suite,9, 10 but their use may result in a higher cost than when administered in the sedation room.11 Unfortunately, it remains a challenge in the sedation room to complete the examinations in children initially sedated using chloral hydrate because of the potential synergistic respiratory depression and airway obstruction with the administration of an additional sedative/anesthetic agent.12

Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with sedative and mild analgesic effects. Evidence has suggested that IV dexmedetomidine provides an advantage in pediatric sedation during noninvasive diagnostic procedures, such as nuclear medicine imaging.13 Although the bioavailability of intranasal dexmedetomidine may be reduced, the advantage of administering intranasal dexmedetomidine over IV dexmedetomidine is that IV cannulation is not required. Furthermore, intranasal dexmedetomidine could be used for rescue sedation after chloral hydrate failure by providing moderate to deep sedation in children scheduled to undergo computed tomography.14 The sedation produced by dexmedetomidine has been shown to be similar to natural sleep, which suggests that dexmedetomidine minimally influences respiratory depression.15 Thus, we hypothesized that intranasal dexmedetomidine administered in the sedation room can provide effective rescue sedation after initial chloral hydrate failure during ophthalmic examination, without increasing adverse events. This hypothesis was tested by assessing the efficacy and tolerability of dexmedetomidine 1 or 2 μg/kg in children who failed chloral hydrate sedation.

Section snippets

Patients and Methods

The protocol of this single-center, prospective, randomized, controlled trial (ClinicalTrials.gov identifier: NCT02077712) was approved by the institutional review board at the Zhongshan Ophthalmic Center (Guangzhou, People’s Republic of China). Written informed consent was obtained from at least one parent of each participating child, and the tenets of the Declaration of Helsinki were followed throughout the study.

General Characteristics

A total of 60 patients who initially failed chloral hydrate sedation with a single 80-mg/kg dose were enrolled to receive intranasal dexmedetomidine. Of the 60 children, 51 had vomited after oral chloral hydrate administration, and 9 had experienced diarrhea after rectal administration. The ages, weights, sex ratios, and American Society of Anesthesiologists physician status were not significantly different between the 2 groups (Table).

Successful Sedation Rate

Although the patients had failed chloral hydrate sedation

Discussion

In the present study, we demonstrated that 1 or 2 μg/kg of intranasal dexmedetomidine can provide sedation sufficient for completing routine follow-up ophthalmic examinations in pediatric patients from the Childhood Cataract Program of the Chinese Ministry of Health who initially failed choral hydrate sedation. Furthermore, adverse events, such as hemodynamic disturbances and respiratory depression, were absent after the administration of either dose of intranasal dexmedetomidine; notably,

Conclusions

The present study is among the first to report that intranasal dexmedetomidine can be administered for rescue sedation in children undergoing noninvasive ophthalmic examination after choral hydrate failure, without accompanying clinically significant complications, and that the 2-μg/kg dose was more effective than was the 1-μg/kg dose, as measured using the rate of successfully completed ophthalmic examinations.

Conflicts of Interest

The authors have indicated that they have no conflicts of interest with regard to the content of this article.

Acknowledgments

This study was funded by the Key Projects for Hospital Clinical Disciplines of the Ministry of Health of China in 2010–2012 Project 175 in Document 439 of the Planning and Finance Secretary of the Ministry of Health, and was supported by the National Natural Science Foundation of China grant 81270980, Guangdong Technology Program grant 2009B080701017, Pearl River Science and Technology New Star grant 2014J2200060, and Project of Guangzhou City and the Guangdong Provincial Natural Science

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    Xiaoliang Gan and Haotian Lin contributed equally to this study and should be considered as co-first authors.

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