Comparison of ease of administration of intranasal midazolam spray and oral midazolam syrup by parents as premedication to children undergoing elective surgery

Manoj, Milthi; Prakash, M. V. S. Satya; Swaminathan, Srinivasan; Kamaladevi, Rithu Krishna

doi:10.1007/s00540-017-2330-6

Cited by 13 publications

(12 citation statements)

References 18 publications

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“…The novel midazolam chocolate tablet was developed following feedback from clinicians about the high rejection rates amongst paediatric patients administered with the commercial and extemporaneously prepared peroral midazolam syrups. The bitter taste of midazolam hydrochloride is notoriously difficult to mask in liquid products; a recent study involving 45 paediatric patients aged 1-6 years old recorded a mean score of 3 (range 2-3 for 'Really Bad' to 'Bad') on a 7-point hedonic scale for a commercial midazolam syrup (23).…”

Section: Discussionmentioning

confidence: 99%

Taste evaluation of a novel midazolam tablet for pediatric patients: In vitro drug dissolution, in vivo animal taste aversion and clinical taste perception profiles

Cheung

Nguyen

Tang

et al. 2018

International Journal of Pharmaceutics

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Harmonized methodologies are urgently required for the taste evaluation of novel pediatric medicines. This study utilized in vitro, in vivo and clinical data to evaluate the palatability of a novel midazolam chocolate tablet. In vitro dissolution experiments showed the crushed tablet to release within 5 min 1.68 mg of midazolam into simulated saliva. This translated to a drug level of 0.84 mg/ml in the oral cavity, which would be higher than the midazolam bitterness detection threshold concentration of 0.03 mg/ml determined in a rat 'brief access taste aversion' (BATA) model. The visual analogue scale scores of patients aged 4-16 years prescribed with midazolam pre-surgery showed a clear preference for the midazolam chocolate tablets (3.35 ± 1.04, n = 20) compared to the control midazolam solution (1.47 ± 0.62, n = 17). The clinical data was in agreement with the in vivo rodent data in showing the novel chocolate tablet matrix to be effective at taste-masking the bitter midazolam.

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Section: Discussionmentioning

confidence: 99%

Taste evaluation of a novel midazolam tablet for pediatric patients: In vitro drug dissolution, in vivo animal taste aversion and clinical taste perception profiles

Cheung

Nguyen

Tang

et al. 2018

International Journal of Pharmaceutics

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“…Midazolam is very commonly used to provide procedural sedation or premedication before anaesthesia in infants, children and adolescents, due to its sedative properties and its rapid onset and short duration of action [1][2][3][4]. Oral formulations of midazolam are easy to administer, are effective in providing sedation, have minimal effects on recovery times and time to discharge, and are well tolerated, as shown in numerous studies of extemporaneous and marketed oral midazolam solutions/syrups in paediatric patients requiring procedural sedation or premedication before anaesthesia [5][6][7][8][9][10][11][12][13][14]. The use of oral midazolam as a premedication may be preferred over the use of midazolam administered by intravenous (IV) injection [10,11], rectal suppository [12] or intranasal spray [13,14].…”

Section: What Is the Rationale For Developing A Novel Oral Solution Omentioning

confidence: 99%

Midazolam oral solution (Ozalin®): a profile of its use for procedural sedation or premedication before anaesthesia in children

Lyseng‐Williamson

2019

Drugs Ther Perspect

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Ozalin ® , a novel oral solution of 0.2% midazolam, is an effective option for moderate sedation prior to a therapeutic or diagnostic procedure, and as premedication before anaesthesia, in infants, children and adolescents. Orally administered midazolam has a rapid onset and short duration of action, with well-established favourable efficacy, tolerability, safety and acceptability profiles in these indications. To overcome the problems of bitter taste and inconsistent bioavailability associated with extemporaneous formulations of oral midazolam, Ozalin, a commercially prepared oral midazolam formulation, contains the inert excipient γ-cyclodextrin, which forms inclusion complexes with midazolam, thereby enhancing the solubility and stability of midazolam solutions, and masking its bitter taste. Ozalin is administered at the lowest dose of midazolam (i.e. 0.25 mg/kg) that has been shown to be effective, with this dose providing sedative effects consistent with the historical data for midazolam at doses that were the same or higher (i.e. 0.5-1.5 mg/kg). Adis evaluation of Ozalin ® for procedural sedation or premedication before anaesthesia in paediatric patients (aged 6 months to 17 years)

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“…While our findings support this matter that intranasal sedation with mucosal atomizer is easier to use and has high acceptability,[ 18 ] in some studies, children preferred to take the liquid form of midazolam, especially syrup in contrast to intranasal form. [ 19 20 ] Fewer patients sedated with oral midazolam accepted this sedation method more easily because children usually resist taking medications, especially liquid or tablet forms due to bitter taste. [ 21 ] The oral liquid forms have different tastes due to added flavors and sweeteners which make them pleasant to be taken by children, and this may be the reason for different acceptance.…”

Section: Discussionmentioning

confidence: 99%

Intranasal midazolam sedation as an effective sedation route in pediatric patients for radiologic imaging in the emergency ward: A single-blind randomized trial

Mayel¹,

Nejad

Khabaz

et al. 2020

Turk J Emerg Med

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OBJECTIVES: Prevention and reduction of pain, anxiety, and fear during medical procedures is one of the most important factors that should be considered in pediatric emergencies. The aim of this study was to compare the efficacy of oral versus intranasal midazolam in sedation during radiologic imaging in the largest province of Iran, Kerman. MATERIALS AND METHODS: Eighty children were enrolled in this single-blind clinical trial based on convenience sampling and were divided into two groups receiving 0.5 mg/kg midazolam in oral route administration and 0.2 mg/kg midazolam in intranasal route administration. Finally, 75 patients remained for evaluating medication acceptability, sedation level, onset time of sedation, additional sedative dose, adverse effects of sedation, and provider satisfaction. RESULTS: Children in the intranasal group accepted medication more easily (89.8% vs. 36.9%; P ≤ 0.001), while these children received a lower sedation dose, but the sedation level in both methods was similar ( P = 0.72). Our findings showed that children in the intranasal sedation group had a faster onset of sedation compared to the oral group (17.94 ± 8.99 vs. 34.50 ± 11.45; P ≤ 0.001). The frequency of midazolam side effects had no difference between the groups (29.7% vs. 15.8%; P = 0.15). CONCLUSION: Intranasal midazolam with a lower sedation dose induces a faster onset and better acceptance. Intranasal midazolam can be used as an effective sedative method for pediatric patients, especially in emergency wards.

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Comparison of ease of administration of intranasal midazolam spray and oral midazolam syrup by parents as premedication to children undergoing elective surgery

Abstract: Oral midazolam syrup is easier for parents to administer and has better medication acceptance in children when compared to intranasal midazolam spray.

Cited by 13 publications

References 18 publications

Taste evaluation of a novel midazolam tablet for pediatric patients: In vitro drug dissolution, in vivo animal taste aversion and clinical taste perception profiles

Taste evaluation of a novel midazolam tablet for pediatric patients: In vitro drug dissolution, in vivo animal taste aversion and clinical taste perception profiles

Midazolam oral solution (Ozalin®): a profile of its use for procedural sedation or premedication before anaesthesia in children

Intranasal midazolam sedation as an effective sedation route in pediatric patients for radiologic imaging in the emergency ward: A single-blind randomized trial

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