Intranasal Midazolam Sedation in a Pediatric Emergency Dental Clinic

Elsheikhomer, Ahmed Mahgoub

doi:10.2344/15-00016.1

Cited by 12 publications

(6 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This reveals that higher dose of intranasal midazolam offers greater probability of children to be calm (sedation scale score 3) during separation from their parents and face mask induction compared to lower dose with no adverse effects. This is similar to studies by Baldwa 12 and Peerbay et al 14 where higher doses were found more effective and in contrast to others showing equivalent sedation levels during parental separation, induction and intravenous cannulation with both the doses, probably due to lesser accurate drug delivery of higher dose. 6,15,16 A study by Al-Rakaf H et al 10 found all three doses (0.3 mgkg −1 , 0.4 mgkg −1 and 0.5mgkg −1 ) of intranasal midazolam effective in modifying the behavior of the uncooperative child to accept dental treatment.…”

Section: Discussionsupporting

confidence: 90%

A study to compare clinical efficacy and safety of two different doses of intranasal midazolam as premedication for paediatric surgery

Sharma¹,

Singh²,

Bawa³

et al. 2020

PJMS

View full text Add to dashboard Cite

Intranasal midazolam is convenient form of premedication in children with favourable pharmacokinetics and no side-effects. This study was carried out to compare two different doses of intranasal midazolam as premedication in paediatric surgery. Materials and Methods: After taking institutional ethics committee approval and informed consent, sixty patients aged 2 to 6 years undergoing elective surgeries were randomised into two groups (n=30 each) to receive 0.2mgkg −1 (Group A) and 0.3 mgkg −1 (Group B) intranasal midazolam in the pre-operative area. Vital parameters were taken at 5 minute intervals till sevoflurane induction. 5-point sedation score was recorded at 5 minutes, 10 minutes, after parental separation at 15 minutes and modified to show compliance with fack mask induction at 20 minutes. Side effects during the study were also compiled. Results: Demographic data including age, gender and weight distribution were comparable in both groups. All haemodynamic parameters remained similar in both the groups (P>0.05). Significantly higher number of patients (24 versus 12 in group B and A respectively) had onset of sedation (score 3, 4) at 5 minutes while sedation levels were comparable at 10 minutes. Lesser number became agitated on parental separation and face mask induction (P-values 0.044, 0.126 respectively) in group B, former being significant. No side effects were observed during the study. Conclusion: Intranasal midazolam in both the dosages provides satisfactory conditions for parental separation and face mask induction in children. However, larger dose can be used for earlier onset, with higher probability of adequate sedation levels, no side effects deterring its use.

show abstract

Section: Discussionsupporting

confidence: 90%

A study to compare clinical efficacy and safety of two different doses of intranasal midazolam as premedication for paediatric surgery

Sharma¹,

Singh²,

Bawa³

et al. 2020

PJMS

View full text Add to dashboard Cite

show abstract

“…The reported drowsiness and relaxation responses in this trial demonstrate that sedation via intranasal dosing with remimazolam is feasible, even with a nonoptimized formulation. Onset times were faster than those typically reported for midazolam, which is used intranasally with some success, e.g., for imaging or in dental practices [11][12][13][14][15]. A limitation of the current trial design was the use of non-optimized IV formulation, resulting in the need to apply large volumes of either solution or powder in order to achieve clinical effects.…”

Section: Discussionmentioning

confidence: 93%

“…The clinical need for intranasal sedation is given by fear of injection, particularly in younger patients. Therefore, to be a clinically useful alternative, intranasal treatment must be demonstrably at least as tolerable as intravenous injection [14]; something which the current intravenous formulation does not seem to offer when administered intranasally: it causes considerable local discomfort (thus negating the purpose of the intranasal route).…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics and pharmacodynamics of intranasal remimazolam—a randomized controlled clinical trial

Pesic

Schippers

Saunders

et al. 2020

Eur J Clin Pharmacol

View full text Add to dashboard Cite

Purpose Remimazolam is a novel and ultra-short-acting sedative currently developed for intravenous use in procedural sedation, general anesthesia, and ICU sedation. However, intravenous administration is not always appropriate, depending on the patient or setting. This study evaluated intranasal administration as a potential alternative route. Methods The study used a randomized, double-blind, 9 period cross-over design to compare the pharmacokinetics, pharmacodynamics, and safety of single intranasal doses of 10, 20, and 40 mg remimazolam (as powder or solution) with intranasal placebo and 4 mg intravenous remimazolam. Results Intranasal remimazolam powder had a consistent absolute bioavailability of approximately 50%; Tmax was 10 min; AUC and Cmax were dose-proportional. The higher doses of intranasal solution, however, resulted in decreasing bioavailability and loss of dose-proportionality in AUC and Cmax despite complete drug absorption due to partial swallowing of dose and the resulting first-pass effect. Pharmacodynamics were generally consistent with PK. Peak effects (drowsiness, relaxation, any, memory, response time) were in similar ranges after intranasal (10 to 40 mg) as intravenous (4 mg) dosing and were partially, but not consistently, dose-related. Safety results were generally consistent with other benzodiazepines; however, intranasal remimazolam (but not placebo) caused nasal discomfort/pain, in some cases even severe. Conclusions Intranasal administration of remimazolam was safe and caused sedative effects. However, the severe pain and discomfort caused by intranasal remimazolam prohibit its use by this route of administration, at least with the currently available intravenous formulation.

show abstract

“…[4] It is useful in those patients whose anxiety levels are more and who are unlikely to cooperate during minor oral surgical procedures, and can be induced by various routes of administration such as inhalation, intranasal (IN) spray, IV, oral, and intramuscular routes. [5] In this study, patients were chosen for IN and IV routes of midazolam administration.…”

Section: Discussionmentioning

confidence: 99%

Comparative analysis of intravenous midazolam with nasal spray for conscious sedation in minor oral and maxillofacial surgeries

Kunusoth

Kkr

et al. 2019

J Pharm Bioall Sci

View full text Add to dashboard Cite

Aim: The aim of the current study was to evaluate the efficacy of nasal spray midazolam by collating it with conventional intravenous midazolam for conscious sedation in minor oral surgeries. Materials and Methods: Sixty patients were selected randomly and divided into two groups: group A for intranasal midazolam atomized spray ( n = 30) and group B for intravenous midazolam ( n = 30). Physiological parameters, anxiety score, sedation rating, patient’s cooperation score, and retrograde and anterograde amnesia were recorded for each patient during preoperative, intraoperative, and postoperative period. Final evaluation of safety and efficacy in the nasal and intravenous routes of midazolam drug during minor oral surgery was compared. Results: In this study, both intranasal and intravenous groups showed decrease in systolic blood pressure and diastolic blood pressure intraoperatively but within physiological limits and increase in the average pulse rates in both the groups. The average oxygen saturation levels were maintained to normal range in both the groups. The average respiratory rate decreased in both intranasal and intravenous groups during surgical procedure. The preoperative to postoperative anxiety scores were decreased significantly in the both groups and there was no significant difference in pre- to postoperative anxiety scores between the groups. Conclusion: Both intravenous and intranasal administration of midazolam showed better patient cooperation, satisfaction, and clinical effectiveness. Intranasal midazolam spray is effective in the reduction of subjective stress, reliable anxiolysis while preserving protective reflexes.

show abstract

Intranasal Midazolam Sedation in a Pediatric Emergency Dental Clinic

Cited by 12 publications

References 10 publications

A study to compare clinical efficacy and safety of two different doses of intranasal midazolam as premedication for paediatric surgery

A study to compare clinical efficacy and safety of two different doses of intranasal midazolam as premedication for paediatric surgery

Pharmacokinetics and pharmacodynamics of intranasal remimazolam—a randomized controlled clinical trial

Comparative analysis of intravenous midazolam with nasal spray for conscious sedation in minor oral and maxillofacial surgeries

Contact Info

Product

Resources

About