Preoperative anxiety in preschool children: A randomized clinical trial comparing midazolam, clonidine, and dexmedetomidine

Bromfalk, Åsa; Myrberg, Tomi; Walldén, Jakob; Engström, Åsa; Hultin, Magnus

doi:10.1111/pan.14279

Cited by 29 publications

(35 citation statements)

References 31 publications

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“…While many drugs have been explored in an effort to reduce preoperative anxiety, induce preoperative sedation and facilitate anesthesia induction, no such labelling was granted until recently. None of the major drug classes known to offer pertinent effects (benzodiazepines, NMDA-receptor antagonists, alpha-2-receptor agonists) meet all the requirements for preoperative pharmacological use in children, nor are they labelled for this specific indication [ 1 , 3 , 20 ].…”

Section: Discussionmentioning

confidence: 99%

“…Premedication administered before surgery to reduce stress and facilitate the induction of anesthesia plays an important role in the perioperative management of children [ 1 , 2 ]. Midazolam with its sedative [ 3 ], anxiolytic [ 1 ] and amnesic [ 4 ] effects is a popular drug for these applications and has shown its efficacy in reducing anxiety and in providing adequate sedation [ 3 ]. Strictly speaking, however, midazolam is an intravenous formulation.…”

Section: Introductionmentioning

confidence: 99%

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ADV6209 for Premedication in Pediatric Anesthesia: A Double-Blinded, Randomized Controlled Trial

et al. 2022

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ADV6209, a new formulation of midazolam with the addition of γ-cyclodextrin for oral use, has recently been licensed as the first pediatric sedative in the European Union. We compared the clinical efficacy of ADV6209 to the standard formulation of midazolam in premedication to reduce anxiety in children before anesthesia induction in a randomized, double-blinded controlled trial. Eighty children (ASA I/II; age: 2–8 years) scheduled for elective surgery were randomized to receive 0.25 mg kg−1 of either conventional midazolam or ADV6209. Assessment tools included the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF) as well as scores for oral acceptance of the premedication and facemask acceptance during inhalational anesthesia induction. Mann–Whitney U and Pearson’s chi-square tests were used for comparisons of outcome parameters. The primary outcome parameter of the study (mYPAS-SF anxiety score 30 min after the drug administration) did not reveal any significant intergroup difference between the ADV6209 group and the conventional midazolam group. Both drugs revealed their efficacy in reducing anxiety and in providing adequate sedation. The premedication dose was accepted by all children in the ADV6209 but rejected by 15% in the conventional midazolam group (p = 0.037). Acceptance of facemask placement was not found to differ significantly. No adverse events related to the study medications were noted. ADV6209 was better orally accepted than the conventional midazolam preparation and proved its efficacy in reducing preoperative anxiety. This clinically interesting preparation may alleviate the premedication process of 2−8 year-old children and obviates off-label drug use.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

ADV6209 for Premedication in Pediatric Anesthesia: A Double-Blinded, Randomized Controlled Trial

et al. 2022

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“…While controlled studies are challenging, longstanding clinical experience indicates that rapid reduction of anxiety by benzodiazepines can mitigate the arrhythmogenic effects of increased circulating levels of catecholamines on a damaged cardiac conduction system in anxious or frightened patients with acute myocardial infarction [79]. Benzodiazepines are appropriate for rapid control of anxiety in anticipation of surgery and other procedures or in response to acute injury or illness in children as well as adults [80, 81]. In the absence of any potential return on investment for studies of medications that are off patent, no recent therapeutic studies of benzodiazepines in anxiety have been conducted.…”

Section: Clinical Applications Of Benzodiazepines and Z-drugsmentioning

confidence: 99%

Benzodiazepines Remain Important Therapeutic Options in Psychiatric Practice

Dubovsky

Marshall

2022

Psychother Psychosom

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Benzodiazepines and medications acting on benzodiazepine receptors that do not have a benzodiazepine structure (z-drugs) have been viewed by some experts and regulatory bodies as having limited benefit and significant risks. Data presented in this article support the use of these medications as treatments of choice for acute situational anxiety, chronic anxiety disorders, insomnia, alcohol withdrawal syndromes, and catatonia. They may also be useful adjuncts in the treatment of anxious depression and mania, and for medically ill patients. Tolerance develops to sedation and possibly psychomotor impairment, but not to the anxiolytic effect of benzodiazepines. Sedation can impair cognitive function in some patients, but assertions that benzodiazepines increase the risk of dementia are not supported by recent data. Contrary to popular opinion, benzodiazepines are not frequently misused or conduits to misuse of other substances in patients without substance use disorders who are prescribed these medications for appropriate indications; most benzodiazepine misuse involves medications that are obtained from other people. Benzodiazepines are usually not lethal in overdose except when ingested with other substances, especially alcohol and opioids. Benzodiazepines comprise one of the few classes of psychotropic medication the mechanisms of action of which are clearly delineated, allowing for greater precision in their clinical use. These medications, therefore, belong in the therapeutic armamentarium of the knowledgeable clinician.

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“…Although sedative effects can be obtained by oral administration, there is no consensus on factors other than pharmacokinetics related to sedative effects and on the characteristics of the children in whom it is difficult to obtain a sedative effect. Bromfalk et al 9 reported that preschoolers likely showed higher anxiety due to differences in the pharmacokinetics and an interaction with the nonpharmacological components of the preanesthetic milieu.…”

Section: Introductionmentioning

confidence: 99%

Serum concentration of oral midazolam as pediatric preanesthetic medication and factors related to the sedation level

Matsuda

Takenaka

Kawabata

et al. 2022

Acta Anaesthesiol Scand

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Background: Preanesthetic medication is important to eliminate surgical anxiety in pediatric patients and facilitate their smooth transfer to the operating room.Midazolam is the most commonly used preanesthetic medication. However, it has been reported that the sedative effect varies from patient to patient. In this study, the pharmacokinetics of midazolam were examined, and the aim was to assess the factors affecting the quality of sedation.Methods: The participants were children ranging in age from 6 months to 8 years scheduled for surgery. Midazolam 0.5 mg/kg was administered orally 30 min before entering the operating room, and the sedation level was evaluated at the time of mask application. Blood was collected after slow induction, and the serum concentration of midazolam was measured using high-performance liquid chromatography.Results: A total of 98 patients were registered. There was no difference in serum concentrations between the effective sedation group and the ineffective sedation group (48.0 vs. 49.1 ng/mL), regardless of the effect of midazolam. Percentages of ineffective sedation by age (0 to 7 years) were 66.

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Preoperative anxiety in preschool children: A randomized clinical trial comparing midazolam, clonidine, and dexmedetomidine

Abstract: This is an open access article under the terms of the Creat ive Commo ns Attri bution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 29 publications

References 31 publications

ADV6209 for Premedication in Pediatric Anesthesia: A Double-Blinded, Randomized Controlled Trial

ADV6209 for Premedication in Pediatric Anesthesia: A Double-Blinded, Randomized Controlled Trial

Benzodiazepines Remain Important Therapeutic Options in Psychiatric Practice

Serum concentration of oral midazolam as pediatric preanesthetic medication and factors related to the sedation level

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