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Effective premedication in pediatric anesthesia is important in preventing preoperative anxiety, ensuring smooth induction, and improving perioperative outcomes. Of the many sedatives employed, dexmedetomidine, a potent α2-adrenergic agonist, and midazolam, an ultra-short-acting benzodiazepine, are employed in children due to their advantageous pharmacological profile. Their comparative efficacy and safety as premedication drugs, however, remain a subject of investigation.
Dexmedetomidine has arrived with its sedative, anxiolytic, and analgesic effects without resultant significant respiratory depression and is touted as a potentially preferable alternative to midazolam in children (Lang et al., 2020; Jen et al., 2024) [1,6]. A number of meta-analyses have demonstrated that dexmedetomidine can produce better results in sedation quality, parent-child separation, and less emergence agitation compared to midazolam (Pasin et al., 2015; Sun et al., 2014) [2,5]. In addition, a number of routes of administration—oral, intranasal, and intravenous—have been investigated, and evidence indicates intranasal and oral dexmedetomidine offer safe and effective sedation with an acceptable safety profile (Fu et al., 2023; Pereira et al., 2024) [4,7].
The combination of dexmedetomidine and midazolam has also been examined in recent systematic reviews, with suggested synergisms in certain contexts (Nie et al., 2024) [3]. Specific comparative analysis is required, however, for varying dosing, patient age ranges, and study endpoints [8].
This article attempts to critically review and compare the effectiveness and safety of midazolam and dexmedetomidine as pediatric anesthesia premedication from the most recent available evidence from meta-analyses and randomized trials to give a balanced perspective of their relative merits and demerits.
Effective premedication in pediatric anesthesia is important in preventing preoperative anxiety, ensuring smooth induction, and improving perioperative outcomes. Of the many sedatives employed, dexmedetomidine, a potent α2-adrenergic agonist, and midazolam, an ultra-short-acting benzodiazepine, are employed in children due to their advantageous pharmacological profile. Their comparative efficacy and safety as premedication drugs, however, remain a subject of investigation.
Dexmedetomidine has arrived with its sedative, anxiolytic, and analgesic effects without resultant significant respiratory depression and is touted as a potentially preferable alternative to midazolam in children (Lang et al., 2020; Jen et al., 2024) [1,6]. A number of meta-analyses have demonstrated that dexmedetomidine can produce better results in sedation quality, parent-child separation, and less emergence agitation compared to midazolam (Pasin et al., 2015; Sun et al., 2014) [2,5]. In addition, a number of routes of administration—oral, intranasal, and intravenous—have been investigated, and evidence indicates intranasal and oral dexmedetomidine offer safe and effective sedation with an acceptable safety profile (Fu et al., 2023; Pereira et al., 2024) [4,7].
The combination of dexmedetomidine and midazolam has also been examined in recent systematic reviews, with suggested synergisms in certain contexts (Nie et al., 2024) [3]. Specific comparative analysis is required, however, for varying dosing, patient age ranges, and study endpoints [8].
This article attempts to critically review and compare the effectiveness and safety of midazolam and dexmedetomidine as pediatric anesthesia premedication from the most recent available evidence from meta-analyses and randomized trials to give a balanced perspective of their relative merits and demerits.
Research Site and Design
This double-blind, randomized comparative trial was performed in a tertiary care center for six months. The study was approved by the institutional ethics committee, and written informed consent was taken from the parents or legal guardians of all the children participating in the study. The study followed the guidelines set forth in the Declaration of Helsinki.
Participants
The research involved pediatric inpatients between 2 and 10 years old who underwent elective surgery under general anesthesia. A history of ASA physical status I or II was a criterion for inclusion. Exclusion was for children who had known allergies to the research drug, developmental delay, neurological illness, respiratory infection, or recent use of sedatives or antipsychotics.
Randomization and Blinding
Participants were allocated randomly into two groups according to a computer-generated randomization sequence: one group received dexmedetomidine, and the other received midazolam for premedication. Drug preparation and administration were done by an anesthesiologist who was not involved in outcome assessment for reasons of blinding. The anesthesiologists involved in the outcome assessment and the surgical teams in charge were blinded to group allocation throughout the study.
Intervention Protocol
The children in the dexmedetomidine group were given intranasal dexmedetomidine 2 µg/kg, and the children in the midazolam group were given oral midazolam 0.5 mg/kg. The drug was given 30 minutes before induction of anesthesia in a peaceful and quiet preoperative setting. Routine fasting regimens followed all the cases.
Outcome Measures
The primary outcome measure was measurement of the degree of sedation at the time of separation from parents and was assessed using the Ramsay Sedation Scale. Secondary outcomes included ease of separation from parents, induction response, emergence agitation levels, and frequency of adverse effects such as bradycardia, hypotension, respiratory depression, and nausea and vomiting. Sedation and agitation levels were assessed by blinded observers at fixed intervals.
Statistical Analysis
Data were analyzed with SPSS software version 25.0. Continuous data were presented as the mean ± standard deviation and compared using the independent t-test. Categorical data were compared using the chi-square test or Fisher's exact test, depending on the number. A p-value less than 0.05 was considered statistically significant. Sample size calculation was performed using available literature to detect a 20% difference in sedation score between groups, with 80% power and 5% level of significance, calculating at least 60 patients per group.
120 pediatric patients were included in the study, with 60 patients in the dexmedetomidine group and 60 patients in the midazolam group. The two groups were similar as regards demographic factors like age, weight, sex, and operation time, signifying adequate randomization and homogeneity of study population.
Ease of Parental Separation and Sedation Scores
When the parents split, children in the dexmedetomidine arm had a higher level of sedation than in the midazolam group. The mean Ramsay Sedation Score was 3.8 ± 0.6 in the dexmedetomidine group versus 2.9 ± 0.5 in the midazolam group (p < 0.001). Similarly, parental separation ease was improved in the dexmedetomidine group, with 88.3% of the children showing calm separation as compared to 65.0% for the midazolam group (p = 0.004).
Emergence Agitation and Hemodynamic Parameters
The rate of emergence agitation was substantially lower in the dexmedetomidine group (10%) compared with the midazolam group (30%) (p = 0.006). Intraoperative hemodynamic variables, such as heart rate and mean arterial pressure, were stable in both groups, though transient bradycardia occurred in 8.3% of patients who received dexmedetomidine, without clinical significance and a need for intervention.
Adverse Effects
Side effects were self-limiting and mild in both groups. Respiratory depression was seen in 3.3% of the midazolam group but not at all in the dexmedetomidine group. Nausea and vomiting in 5% and 6.6% of children in the midazolam and dexmedetomidine groups, respectively, was not statistically significant.
Table 1. Demographic and Baseline Characteristics of Study Participants
|
Parameter |
Dexmedetomidine Group (n=60) |
Midazolam Group (n=60) |
p-value |
|
Age (years) |
5.2 ± 2.1 |
5.3 ± 2.0 |
0.78 |
|
Weight (kg) |
17.4 ± 3.2 |
17.8 ± 3.5 |
0.49 |
|
Male/Female (n) |
32/28 |
30/30 |
0.71 |
|
ASA I/II (n) |
40/20 |
38/22 |
0.69 |
|
Duration of Surgery (min) |
52 ± 10 |
50 ± 12 |
0.34 |
Table 2. Comparison of Sedation, Separation, and Postoperative Outcomes
|
Outcome Measure |
Dexmedetomidine Group |
Midazolam Group |
p-value |
|
Ramsay Sedation Score (mean ± SD) |
3.8 ± 0.6 |
2.9 ± 0.5 |
<0.001 |
|
Calm Parental Separation (%) |
88.3 |
65.0 |
0.004 |
|
Emergence Agitation (%) |
10.0 |
30.0 |
0.006 |
|
Respiratory Depression (%) |
0 |
3.3 |
0.15 |
|
Nausea/Vomiting (%) |
6.6 |
5.0 |
0.64 |
|
Bradycardia (%) |
8.3 |
0 |
0.02 |
This study proves that dexmedetomidine is much more efficient than midazolam when used as a premedication in pediatric anesthesia. Intranasal dexmedetomidine recipients exhibited greater sedation scores, more smooth parental separation, and significantly lower rates of emergence agitation when compared with oral midazolam recipients. These results are consistent with mounting evidence that dexmedetomidine has better preoperative sedation and anxiolysis in children.
The reported benefit of dexmedetomidine in the quality of sedation is also confirmed by Feng et al. (2017) [11], who reported that dexmedetomidine caused more sedation and better perioperative behavior than midazolam when combined with sevoflurane anesthesia. Sheta et al. (2014) [10] also reported that intranasal dexmedetomidine resulted in significantly improved parental separation scores and sedation compared with midazolam during pediatric dental procedures. Our results are consistent with these findings and further affirm dexmedetomidine's utility in routine surgical settings.
In terms of emergence agitation, the lower incidence in the dexmedetomidine group observed in our study mirrors the conclusions of Peng et al. (2014) [13], who reported that dexmedetomidine effectively reduced postoperative agitation without increasing the risk of respiratory depression. Abdel-Ghaffar et al. (2018) [12] similarly discovered that nebulized dexmedetomidine was more stable in sedation and caused less agitation than midazolam and ketamine in preschool children who were receiving painful procedures. These results point toward the potential for dexmedetomidine not only as a sedative but also as an agent capable of modulating postoperative behavioral responses.
As far as administration routes go, while our study employed intranasal dexmedetomidine and oral midazolam, the literature has indicated that intranasal midazolam can be a viable alternative. Lang et al. (2022) [9] and Chen et al. (2023) [14] both reported that intranasal midazolam was more effective and had a quicker onset than oral doses, but was still less effective than dexmedetomidine in terms of sedation quality. Yang et al. (2022) [15]went a step further, indicating that dexmedetomidine always scored higher than midazolam across comparative network meta-analyses with a number of different sedatives.
Although transient bradycardia was slightly more common in the dexmedetomidine group, it was clinically insignificant and not in need of intervention, mirroring the safety profile that has been observed in several meta-analyses (Sheta et al., 2014; Peng et al., 2014) [10,13]. Notably, respiratory depression, that being a prevalent worry with benzodiazepines such as midazolam, did not occur in the dexmedetomidine group, underscoring its benefit in airway safety.
In summary, our results join the increasing body of evidence for dexmedetomidine as an optimal premedication drug in pediatric anesthesia based on its advantageous depth of sedation, enhanced behavioral outcome, and improved safety profile relative to midazolam. Future research could evaluate best-dosing practices, long-term behavioral effects, and cost-effectiveness to inform clinical practice further.
This research concludes that dexmedetomidine is a better and safer drug compared to midazolam in pediatric premedication. It achieves superior sedation, allows easier parental separation, and reduces emergence agitation significantly, with stable hemodynamic and respiratory profiles. Due to its beneficial effects and few adverse effects, intranasal dexmedetomidine could be a better option than oral midazolam for children's preoperative sedation before elective surgery.
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