Abstract
Introduction/Background
Lacerations are common in children presenting to the emergency department (ED). Children can be uncooperative and in pain when repair with sutures is performed and may require procedural sedation. There is a growing interest in the intranasal (IN) route of administration for procedural sedation and pain control. In contrast to intravenous (IV) line placement, IN administration is relatively painless for the patient, is simple and rapid to administer by the healthcare provider and requires minimal training. Few studies have evaluated intranasal (IN) ketamine for procedural sedation in children, mostly for brief dental procedures, with doses between 3 to 9 mg/kg.
Objectives
We sought to determine the optimal IN ketamine dose for effective and safe procedural sedation for laceration repair with sutures in children aged 1 to 12 years presenting to the ED using a two-step (dosINK- 1 trial and dosINK-2 trial) dose-finding clinical trial design.
Design/Methods
We enrolled otherwise healthy children 1 to 12 years requiring PS for their laceration repair by sutures in the ED. DosINK-1 consisted in a single center 3 + 3 dose escalation trial design with an initial dose of 3 up to 9 mg/kg of IN ketamine. For each dose, 3 patients were enrolled. Escalation to the next dose was performed if sedation was unsuccessful without serious adverse event (SAE). This process was repeated until 6 consecutive patients reached adequate PS with a maximum of 1 SAE. The primary outcome was the optimal dose for adequate PS as per the PERC/PECARN consensus criteria.
We subsequently conducted DosINK-2, a multicenter single-arm clinical trial. We enrolled a convenience sample of 30 children who all received the identified dose of IN ketamine from DosINK-1. The primary outcome was the proportion (95% CI) of patients who achieved adequate PS. Secondary outcomes included adverse events and parent, patient and physician satisfaction.
Results
In DosINK-1, 12 patients were recruited from April 2017 to March 2018 in one pediatric ED. Median age was 2.6 (interquartile range [IQR] 1.9, 3.7) years, 10 (85%) had facial laceration, and in 8 (67%) the laceration was >2 cm long. Sedation was adequate in 1/3 patients at doses of 3 and 4 mg/kg and in 3/3 patients at doses of 5 and 6 mg/kg, all without SAE. The identified dose of IN ketamine was 6 mg/kg. Nausea and vomiting in 4/12 (33%) patients were the only reported side effects.
In DosINK-2, we recruited 30 patients from April 2018 to November 2019 in two pediatric EDs. The median age was 3.2 (IQR 1.9, 4.7) years; 21 (70%) had facial laceration, and in 20 (67%) the laceration was longer than 2 cm. Sedation was adequate in 18/30 (60% [95% CI 45, 80]) children, was suboptimal (procedure completed with minimal difficulties) in 6 (20%), was poor (struggle that interfered with procedure, competed with difficulty) in 3 (10%) and required additional sedative agents in 3 (10%) patients. Twenty-one (70%) physicians were willing to reuse IN ketamine at the same doses and 25 (83%) parents would agree to the same sedation in the future. Median time to return to baseline status was 58 min (IQR 33, 73). Two patients, including one who received supplemental IV ketamine, desaturated during the procedure and required oxygen by-mask and repositioning. After the procedure, 1(3%) patient had nausea, and 2(7%) vomited.
Conclusion
A single dose of 6 mg/kg of IN ketamine for PS during laceration repair by sutures in children in the ED was adequate in 60%(95% CI 45, 80). In an additional 20% PS was suboptimal, but procedures were completed with minimal difficulties only. IN ketamine, which saves painful IV insertion, was acceptable by most physicians and parents. An additional IN ketamine dose may further increase the proportion of adequate sedation, but its safety and efficacy should be examined.
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