Wilson
et al., 2002 [18[18] Wilson KE, Welbury RR, Girdler NM. A randomised, controlled, cross-over trial of oral midazolam and nitrous oxide for paediatric dental sedation. Anaesthesia 2002; 57(9):860-867. https://doi.org/10.1046/j.1365-2044.2002.02784.x
https://doi.org/10.1046/j.1365-2044.2002...
] |
UK |
RCCT
N=46
10-16 years |
Orthodontic extraction of at least 4 teeth (premolars or canines) |
0.5 mg/kg oral midaz |
30/70% |
i)Behaviour
ii)Level of sedation
iii)Physiologic status
iv)Dental anxiety
v)General Anxiety
vi)Adverse effects |
i)HBRS
ii) Breitkopf and Buttner-Classification of emotional status
iii)Pulse, respiratory rate, SPO2
iv)Children’s fear survey schedule dental subscale
v)Spielberger state anxiety inventory
vi)Post-operative questions |
i)Behaviour: The overall score was similar in both groups. 1 procedure in each group was aborted
ii)Level of sedation: Higher in the midaz group than the N2O group
iii) Lowest median SPO2: N2O group - 98%, Midaz group - 95% (p<0.001)
Mean respiratory rate: N2O group - 15.8 breaths/min, Midaz group - 15.5 breaths/min
iv)Dental anxiety: For midaz - The mean score when used in 1st visit was 32, and 2nd visit was 30. For N2O - Mean score in 1st visit 30 and 2nd visit mean score was 26
v)General anxiety: Score ranged from 20 to 73, but both groups showed a decrease in general levels of anxiety
vi)Amnesia - Seen in 6 children in the nitrous group and 39 children in the midaz group (p<0.001)
|
Oral midazolam is as effective as N2O for controlling behaviour. Midaz shows higher levels of sedation and amnesic effects. SPO2 levels for midaz were significantly lower than those of the N2O group. |
Wilson
et al., 2002 [19[19] Wilson KE, Welbury RR, Girdler NM. A study of the effectiveness of oral midazolam sedation for orthodontic extraction of permanent teeth in children: a prospective, randomised, controlled, cross-over trial. Br Dent J 2002; 192(8):457-462. https://doi.org/10.1038/sj.bdj.4801400
https://doi.org/10.1038/sj.bdj.4801400...
] |
UK |
RCCT
N=26
10-16 years |
Orthodontic extraction of premolar or canines |
0.5 mg/kg oral midaz |
30/70% |
i)Behaviour
ii)Level of sedation
iii)Physiologic status
iv)Adverse effects |
i)HBRS
ii)Breitkopf and Buttner-Classification of emotional status
iii)Pulse, respiratory rate, SPO2
iv) Post-operative questions |
i)Behaviour: N2O - 21 children scored 6 (excellent), 3 scored 5 (very good),1 scored 4 (good), 1 aborted treatment
Midaz-18 children scored 6(excellent), 3 scored 5 (very good),2 scored 4 (good), 2 scored 3 (fair), and 1 aborted treatment
ii)Level of sedation: N2O group - 24 children scored 2 (awake & calm), and 2 children scored 3 (tired, hardly moving) Midaz group - 7 children scored 2, 13 children scored 3, and 4 children scored 4(drowsy without reaction but arousable)
iii)Lowest mean SPO2: N2O group - 97.7%; Midaz group - 95%
Mean respiratory rate: N2O group - 14.8 breaths; Midaz group - 14.6 breaths
iv) Amnesia - 3 children in the nitrous group and 20 children in the midaz group (p<0.001)
Sleepiness/dizziness/slight headachereported in 19% of patients in both groups |
Oral midaz is as effective as N2O in controlling behaviour and sedation. One case of paradoxical reaction was reported with midaz, due to which treatment was aborted. Oral midazolam produces significant amnesic effects. |
Wilson
et al., 2003 [8[8] Wilson KE, Girdler NM, Welbury RR. Randomized, controlled, cross-over clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions. Br J Anaesth 2003; 91(6):850-856. https://doi.org/10.1093/bja/aeg278
https://doi.org/10.1093/bja/aeg278...
] |
UK |
RCCT
N=42
12-16 years |
Orthodontic extraction of at least 4 teeth (premolars or canines) |
Intravenous midaz (rate 0.5 mg min, max 5 mg) |
30/70% |
i)Behaviour
ii)Level of sedation
iii)Physiologic status
iv)Adverse effects
v)Onset of sedation
vi) Recovery time |
i)HBRS, Frankl Scale
ii)Breitkopf and Buttner-Classification of emotional status
iii)Blood pressure, Pulse rate, Ventilatory frequency, SPO2
iv) Self-reported |
i) Overall behaviour: No significant difference between both groups
ii) Level of sedation: In the recovery phase, sedation levels of the midaz group were higher than those of the N2O group. There is no significant difference between both in the other stages of treatment.
iii)SPO2: No significant difference between both groups
iv) Adverse effects: 14 patients in the midaz group and 11 in the N2O group reported effects including nausea, vomiting, drowsiness, headache, and sore mouth.
v) Median onset to maximum sedation: N2O group: 6 (2-18)min; Midaz group 8 (4-20)min (p<0.001)
vi) Mean recovery time: N2O group: 23.3min (2-18); Midaz group - 51.6 min |
Intravenous midaz is as effective as N2O in providing satisfactory sedation and overall behaviour. It shows a slower onset of action than N2O and a longer recovery time. Administration of IV midaz requires a specialist trained in pediatric sedation and life support. |
Wilson
et al., 2006 [20[20] Wilson KE, Girdler NM, Welbury RR. A comparison of oral midazolam and nitrous oxide sedation for dental extractions in children. Anaesthesia 2006; 61(12):1138-1144. https://doi.org/10.1111/j.1365-2044.2006.04835.x
https://doi.org/10.1111/j.1365-2044.2006...
] |
UK |
RCCT
N=42
5-10 years |
Extraction of at least 4 primary teeth, one in each quadrant |
0.3mg/kg oral midaz |
30/70% |
i)Behaviour
ii)Level of sedation
iii)Physiologic status
iv)Adverse effects
v)Time to max sedation |
i)HBRS
ii)Breitkopf and Buttner-Classification of emotional status
iii)Heart rate, respiratory rate, SPO2, Mean arterial blood pressure
iv) Post-operative questions |
i)Behaviour: No disruptive behaviour in the N2O group. 5% of the children were uncooperative after oral midazolam. 3 and 2 children were unable to tolerate oral midaz and N2O, respectively, and hence dropped out
ii) Level of sedation: Midaz group: 70% were drowsy (score 4); N2O group: 85% were tired (score 3)(p<0.001)
iii) Vitals: Within acceptable limits in both groups
iv) Adverse effects: 20% after midaz and 23% after N2O showed drowsiness and headache. Procedural amnesia higher in midaz group (p=0.031) |
Oral midaz produced greater levels of sedation and showed more procedural amnesia than N2O. It may not be the preferred technique, but it may be more appropriate for some, depending on their treatment requirement and anxiety. |
Wilson
et al., 2007 [21[21] Wilson KE, Welbury RR, Girdler NM. Comparison of transmucosal midazolam with inhalation sedation for dental extractions in children. A randomized, cross-over, clinical trial. Acta Anaesthesiol Scand 2007; 51(8):1062-1067. https://doi.org/10.1111/j.1399-6576.2007.01391.x
https://doi.org/10.1111/j.1399-6576.2007...
] |
UK |
RCCT
N=36
10-15 years |
Orthodontic extractions of 4 premolars |
0.2mg/kg transmucosal (buccal) midaz |
30/70% |
i)Behaviour
ii)Level of sedation
iii)Pre& post-op dental anxiety
iv)General Anxiety
v)Physiologic signs
vi) Adverse effects |
i)HBRS
ii)Breitkopf and Buttner's Classification of emotional status
iii) Children’s fear survey schedule dental subscale
iv)Spielberger state anxiety inventory
v)Blood pressure, pulse rate, respiratory rate, SPO2
vi)Self-reported |
i)Behaviour: No significant difference
ii) Level of sedation: 36/36 in midaz and 35/36 in N2O group scored 3 (tired)
iii)Dental anxiety: Mean score pre-op 31.9
Post-op score 27.1 (p<0.001)
iv)General anxiety: Mean pre-op score 45.5
Mean post-op score 39.4 (p<0.001)
v)Lowest SPO2 in midaz group: 94%
vi)Adverse effects: Sleepiness/headache/slight nausea seen in 16/36 under midaz & 14/36 under N2O |
Transmucosal midaz is as effective as N2O in controlling behaviour and sedation. Anxiety decreased significantly throughout the study. |
Srinivasan et al., 2021 [22[22] Srinivasan NK, Karunagaran P, Panchal V, Subramanian E. Comparison of the sedative effect of inhaled nitrous oxide and intranasal midazolam in behavior management and pain perception of pediatric patients: A split-mouth randomized controlled clinical trial. Int J Clin Pediatr Dent 2021; 14(Suppl 2):S111-S116. https://doi.org/10.5005/jp-journals-10005-2085
https://doi.org/10.5005/jp-journals-1000...
] |
India |
RCCT
N=35
4-7 years |
Bilateral pulp therapy |
0.3mg/kg intranasal midaz |
30/70% |
i)Behaviour
ii)Pain
iii)Level of sedation
iv)Physiologic signs
v)Adverse effects |
i)HBRS
ii)FLACC score
iii)Ellis sedation scale
iv)SPO2, HR, RR
v)Scale by Shashikiran et al. |
i)Behaviour: Excellent behaviour of 57.1% under N2O and 51.4% under midaz
ii)Pain: Mean FLACC score 1.57 ± 2.6 for N2O and 2.77 ± for midaz (p<0.001)
iv)Heart rate: 106.64 ±12.68 bpm for N2O and 103.29±12.69bpm for midaz when administering LA (p<0.001)
v)Adverse effects: N2O - vomiting (2.2%)
Midaz - sneezing/coughing/hiccups (n=4) |
Intranasal midaz is as effective as N2O in controlling behaviour and sedation. Dental treatment was successfully completed in both groups. |
Ann Preethy and Somasundaram, 2022 [23[23] Ann Preethy N, Somasundaram S. Safety and physiologic effects of intranasal midazolam and nitrous oxide inhalation based sedation in children visiting Saveetha Dental College and Hospitals, India. Bioinformation 2022; 18(1):26-35. https://doi.org/10.6026/97320630018026
https://doi.org/10.6026/97320630018026...
] |
India |
RCCT
N=35
4-8 years |
Bilateral mandibular pulpectomy |
0.3mg/kg intranasal midaz |
30/70% |
i)Level of sedation
ii)Physiologic signs
iii)Adverse effects
iv) Onset of sedation |
i)Modified Ramsay Sedation scale
ii)Heart rate, respiratory rate, SPO2
iii)Safety scale by Shashikiran et al. |
i) Level of sedation: Moderate in both groups with no statistical difference
ii)All vitals within acceptable limits with both agents.
Heart rate: Statistically significant higher heart rate during LA administration in the midaz group than the N2O group (p=0.00)
iii)Adverse effects: N2O group - 5 children vomited. Midaz group - 4 participants showed sneezing/coughing/hiccups
iv) Onset of sedation: The lesser time required for the onset of sedation in midaz group (p=0.000)
|
Intranasal midaz is as effective as N2O in providing safe and satisfactory sedation. It also shows a faster onset of action than N2O. |
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