Utility of intranasal Ketamine and Midazolam to perform gastric aspirates in children: a double-blind, placebo controlled, randomized study

BMC Pediatrics

Antonio Chiaretti¹  Riccardo Riccardi¹  Filomena Pierri¹  Piero Valentini¹  Giovanni Barone¹  Danilo Buonsenso¹ 

[1] Department of Pediatric Sciences, Catholic University of Rome, Largo A. Gemelli, 1, 00168 Rome, Italy

关键词: Gastric washings;    Tuberculosis;    Ketamine;    Midazolam;    Intranasal sedation;   

Others  :  1138965
DOI  :  10.1186/1471-2431-14-67

 received in 2013-09-21, accepted in 2014-02-18,  发布年份 2014

【 摘 要 】

Background

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. 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.

Methods

In 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.

Results

Fifty-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%).

Conclusions

Our experience suggests that atomized INKM makes gastric aspirates more acceptable and easy to perform in children.

Trial registration

Unique trial Number: UMIN000010623; Receipt Number: R000012422.

【 授权许可】

   
2014 Buonsenso et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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