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The Injection Rate of Intravenous Midazolam Significantly Influences the Occurrence of Paradoxical Reaction in Pediatric Patients

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The Injection Rate of Intravenous Midazolam Significantly Influences the Occurrence of Paradoxical Reaction in Pediatric Patients The injection rate of intravenous midazolam significantly influences the occurrence of RTICLE paradoxical reaction in pediatric patients A Abbas Moallemy, Saeed Hoseini Teshnizi1, Masood Mohseni2 Department of Anesthesiology, 1Department of Biostatistics, Hormozgan University of Medical Sciences, Hormozgan, 2Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran Background: Paradoxical reactions to benzodiazepines including restlessness, anxiety and sometimes violent behavior sometimes occur. Most of the known predicting factors of disinhibitory reactions such as age, gender, genetic or the psychological background RIGINAL are not modifiable. This study was conducted to evaluate the effect of rate of midazolam administration, as a controllable factor, on the occurrence of paradoxical reaction to midazolam (PRM) in pediatric patients. Materials and Methods: In a randomized, double- O blind clinical trial 98 American Society of Anesthesiologists physical status I, II, aged from 6 months to 6 years, and undergoing elective surgery, were enrolled in the study. Patients were randomly allocated to receive midazolam 0.1 mg/kg as a 0.1% solution at an injection rate of 0.2 ml/s or 1 ml/s. The occurrence of PRM was compared between the two groups with Chi-square test. Results: The occurrence of PRM in the rapid injection group was significantly higher than the slow injection group (20.4% vs. 4.1%, P < 0.05, relative risk CI: 95% 6.03 (1.24-29.4)). Conclusion: Slow intravenous administration of midazolam significantly reduces the occurrence of paradoxical reactions and should be respected in premedication of pediatric patients. Key words: Administration rate, midazolam, paradoxical reaction, premedication How to cite this article: Moallemy A, Teshnizi SH, Mohseni M. The injection rate of intravenous midazolam significantly influences the occurrence of paradoxical reaction in pediatric patients. J Res Med Sci 2014;19:965-9. INTRODUCTION It has been suggested that higher doses of benzodiazepines are correlated with more occurrence Benzodiazepines are administered to pediatric patients of disinhibitory reactions.[9,19] Another factor known to preoperatively to provide anxiolysis, amnesia, and influence some drug reactions is the speed of intravenous sedation.[1-5] However, patients sometimes show administration.[20] However, the impact of this factor on paradoxical reaction to benzodiazepines and become the occurrence of PRM has not been studied before. This restlessness, anxious or even aggressive.[6-10] Paradoxical study was conducted to compare two rates of midazolam reaction following midazolam administration is an administration (0.2 ml/s vs. 1 ml/s of 0.1% solution) on unpleasant experience for the children and makes the occurrence of PRM in pediatric patients. their parents and the operating room personnel worrisome. Most earlier studies focused on the MATERIALS AND METHODS treatment of paradoxical reaction to midazolam (PRM), while the recommended medications including Study design and participants the flumazenil, physostigmine, haloperidol, larger This randomized double-blind clinical trial was doses of benzodiazepines and ketamine have several approved by the Research Ethics Committee of potential adverse effects,[11-15] and reported to be only Hormozgan University and written informed consent partially effective.[5,9] Thus, an important element of our was obtained from the parents of all patients. Between practice should be to try to reduce the occurrence of June 2008 and February 2009, a total of 98 American paradoxical reactions. Noteworthy, we cannot make an Society of Anesthesiologists physical status I, II patients, intervention on most of the suggested predicting factors aged from 6 months to 6 years, and undergoing elective of paradoxical reaction such as age, gender, genetic[10,16] surgery, were enrolled in the study. Patients with a or the psychological background[17,18] of the patients. history of psychological disorders, mental retardation, Thus, it would be reasonable to focus on the profile of previous surgical procedures, receiving sedative or administered medications that is potentially modifiable. herbal medications and those who had preoperative Address for correspondence: Dr. Masood Mohseni, Department of Anesthesiology, Iran University of Medical Science, Tehran, Iran. E-mail: [email protected] Received: 27-07-2013; Revised: 24-11-2013; Accepted: 06-08-2014 965 Journal of Research in Medical Sciences | October 2014 | Moallemy, et al.: Injection rate of midazolam pain were not included in the study. needing restraint).[21] The sample size was calculated based on the estimation After approximately 1 min of midazolam administration, equation of sample size for two ratios, with estimated the children were transported to the nearby operating room incidence of PRM in slow and rapid injection groups as while one parent attended the children. Asingle anesthetist 5% and 30%, respectively. Based on 0.9 power to detect a who was blinded to the nature of assignments observed significant difference and α level of 0.05, 45 patients in each the patients for 10 min for the occurrence of paradoxical group was estimated to be appropriate. Additional four reactions. He was not present in the premedication room patients were added to compensate for possible dropouts. and was blinded to the allocations as well as children’s baseline calmness scores. The diagnosis of PRM was Procedures made based on the observation of a sudden occurrence Patients were randomly allocated to receive midazolam of restlessness, agitation, anxiety, inconsolable crying (Dormicum®; Roche, Brussels, Belgium) 0.1 mg/kg as 0.1% or aggressive behavior after a transient sedative state.[8] solution in distilled water at an injection rate of either Induction of general anesthesia was performed after 10 min 0.2 ml/s (rapid injection group) or 1 ml/s (slow injection of assessment and earlier in the case of PRM. During the group). Block randomization with a block size of 4 was preinduction period, vital signs as well as oxygen saturation considered to assign an equal number of individuals to of patients were monitored continuously. Age, weight, sex each group. The drug was administered by one anesthetist and the occurrence of PRM were recorded in children. The in the calm environment of premedication room while the study design has been summarized in Figure 1. children were left free in a sitting or supine position or even in the arm of their parents. Midazolam was infused manually using a chronometer. All children had intravenous Statistical analysis access before transfer to the operating room. Nurses in our Data are presented as means (standard deviation) or pediatric ward usually use most easily accessible veins in the percentages, as appropriate. Baseline characteristics and children’s hand or forearm. Angiocatheter number 22 was outcome measures of the two groups were analyzed with most often used for intravenous access. The interval between Student’s t-test for continuous data and Chi-square test intravenous line insertion in the ward and admission to for categorical analysis. Calmness scale was presented the operating room was at least 2 h. Before midazolam as median and interquartile range and analyzed with administration, the anesthetist recorded a calmness Mann–Whitney U-test. All comparisons were two-tailed. score using a 5-point Likert scale (4= spontaneously Statistical analyses were performed with Statistical calm, 3= calmed after reassurance, 2= crying, 1= agitated Package for the Social Sciences (SPSS) version 16.0 software with violent crying, 0= uncontrollable, inconsolable, and (SPSS, Inc., Chicago, IL, USA). Figure 1: The consort flow diagram of the study | October 2014 | Journal of Research in Medical Sciences 966 Moallemy, et al.: Injection rate of midazolam RESULTS familiar explained clinical picture and ruling out other causes of agitation, including hypoxia, hypotension and The study population included 76 boys and 22 girls with pain. Moreover, because no other drug was administered the average age of 28 ± 16 months. The most common site during the evaluation period, the possibility of reaction to of surgery was lower abdomen, followed by ear, nose, and other drugs is excluded. throat. The two groups were comparable respecting the baseline characteristics and calmness scores [Tables 1 and 2]. Given that paradoxical reactions to benzodiazepines are mostly uncharacteristic, defining diagnostic criteria would The incidence of PRM in the rapid injection group be difficult. The diagnosis usually relies on the subjective was significantly greater than the slow injection judgment of the clinician when significant deviation from group (20.4% vs. 4.1%, P = 0.02). The relative risk was predicted normal behavior encountered. DeMascio and 6.03 (95% CI, 1.24, 29.4). The incidence of PRM in the first Shades proposed the following definition for “behavioral quartile of age (14 months) was 4/27 (14.8%), in the second toxicity” following medication use. “Behavioral toxicity quartile (15-24 months) was 5/22 (22.7%) and in the is a phrase used to denote those pharmacological third quartile (25-40 months) was 3/22 (12%). None of the reactions of a drug that, when administered within the 24 children older than 40 months experienced PRM (P = 0.02). dose range in which it has been found to possess clinical None of the patients experienced hypoxia, bradycardia or utility produce-through mechanisms not immediately severe hypotension
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