Abstract
BackgroundWe performed a prospective, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal Ketamine and Midazolam (INKM) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis. Primary outcome: evaluation of Modified Objective Pain Score (MOPS) reduction in children undergoing INKM compared to the placebo group. Secondary outcomes: evaluation of safety of INKM protocol, start time sedation effect, duration of sedation and evaluation of parents and doctors’ satisfaction about the procedure.MethodsIn the sedation group, 19 children, mean age 41.5 months, received intranasal Midazolam (0.5 mg/kg) and Ketamine (2 mg/kg). In the placebo group, 17 children received normal saline solution twice in each nostril. The child’s degree of sedation was scored using the MOPS. A questionnaire was designed to evaluate the parents’ and doctors’ opinions on the procedures of both groups.ResultsFifty-seven gastric washings were performed in the sedation-group, while in the placebo-group we performed 51 gastric aspirates. The degree of sedation achieved by INMK enabled all procedures to be completed without additional drugs. The mean duration of sedation was 71.5 min. Mean MOPS was 3.5 (range 1-8) in the sedation-group, 7.2 (range 4-9) in the placebo-group (p <0.0001). The questionnaire revealed high levels of satisfaction by both doctors and parents in the sedation-group compared to the placebo-group. The only side effect registered was post-sedation agitation in 6 procedures in the sedation group (10.5%).ConclusionsOur experience suggests that atomized INKM makes gastric aspirates more acceptable and easy to perform in children.Trial registrationUnique trial Number: UMIN000010623; Receipt Number: R000012422.
Highlights
We performed a prospective, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal Ketamine and Midazolam (INKM) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis
In this study we prospectively evaluated the efficacy and safety of a sedation protocol based on intranasal combination of Ketamine and Midazolam (INKM) administered by Mucosal Atomizer Device (MAD), in children undergoing gastric aspirates for suspected pulmonary TB
In the sedation-group, children received 2 mg/kg of Ketamine hydrochloride administered by a physician in both nostrils followed by 0.5 mg/kg of Midazolam using a 2.5 mL syringe connected to a MAD (Wolfe Tory Medical, Salt Lake City, Utah, USA) (Figure 1)
Summary
We performed a prospective, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal Ketamine and Midazolam (INKM) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis. A Mucosal Atomizer Device (MAD) delivers medications via a fine spray over a broad surface area in the nasal cavity. It reduces sneezing and coughing compared to other devices [9]. Its activity has some advantages, such as preservation of respiratory reflexes and an intrinsic positive inotropic effect [15] It is an excellent analgesic, sedative and amnestic agent. Midazolam-Ketamine combination has been used for different pediatric procedures inside and outside the operating room, for its anxiolytic and analgesic effects, in order to obtain more analgesia, less hypotension, the use of a lower doses of drugs, and, a lower risk of respiratory depression [16]
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