Efficacy and Safety of Oral Midazolam Sedation Compared with its Combination with Hydroxyzine Use in Pediatric Dentistry: A Systematic Review

Oliveira, Gustavo Henrique Porto; Brandão, Diogo Gomes; Lima, Fernando José Camello de; Nascimento, Patricia Batista Lopes do; Marcelos, Priscylla Gonçalves Correia Leite de; Pugliesi, Daniela Maria Carvalho; Cosme-Silva, Leopoldo; Santos Júnior, Valdeci Elias dos

doi:10.1590/pboci.2023.014

Gustavo Henrique Porto Oliveira

Investigation

Writing - Original Draft

All authors declare that they contributed to critical review of intellectual content and approval of the final version to be published

Department of Pediatric Dentistry, School of Dentistry, Federal University of Alagoas, Maceió, AL, Brazil

http://orcid.org/0000-0002-7796-5359

Diogo Gomes Brandão

Investigation

Writing - Original Draft

All authors declare that they contributed to critical review of intellectual content and approval of the final version to be published

Department of Pediatric Dentistry, School of Dentistry, Federal University of Alagoas, Maceió, AL, Brazil

http://orcid.org/0000-0001-6167-0399

Fernando José Camello de Lima

Conceptualization

Methodology

Writing - Original Draft

Writing - Review and Editing

Project Administration

All authors declare that they contributed to critical review of intellectual content and approval of the final version to be published

Department of Biological Science, Federal University of Alagoas, Maceió, AL, Brazil

http://orcid.org/0000-0003-1593-7747

Patricia Batista Lopes do Nascimento

Investigation

Writing - Original Draft

All authors declare that they contributed to critical review of intellectual content and approval of the final version to be published

Department of Pediatric Dentistry, School of Dentistry, Federal University of Alagoas, Maceió, AL, Brazil

http://orcid.org/0000-0002-2355-4810

Priscylla Gonçalves Correia Leite de Marcelos

Investigation

Writing - Original Draft

All authors declare that they contributed to critical review of intellectual content and approval of the final version to be published

Department of Pediatric Dentistry, School of Dentistry, Federal University of Alagoas, Maceió, AL, Brazil

http://orcid.org/0000-0002-5623-6835

Daniela Maria Carvalho Pugliesi

Investigation

Writing - Original Draft

All authors declare that they contributed to critical review of intellectual content and approval of the final version to be published

Department of Pediatric Dentistry, School of Dentistry, Federal University of Alagoas, Maceió, AL, Brazil

http://orcid.org/0000-0002-7854-0416

Leopoldo Cosme-Silva

Methodology

Writing - Original Draft

All authors declare that they contributed to critical review of intellectual content and approval of the final version to be published

Department of Pediatric Dentistry, School of Dentistry, Federal University of Alagoas, Maceió, AL, Brazil

http://orcid.org/0000-0002-5755-1933

Valdeci Elias dos Santos JúniorCorrespondence: Valdeci Elias dos Santos Júnior, Department of Pediatric Dentistry, School of Dentistry, Federal University of Alagoas, Rua Lourival Melo Mota, S/N, Tabuleiro do Martins, Maceió, AL, Brazil. E-mail:valdeciodonto@gmail.com

Conceptualization

Methodology

Writing - Original Draft

Writing - Review and Editing

All authors declare that they contributed to critical review of intellectual content and approval of the final version to be published

Department of Pediatric Dentistry, School of Dentistry, Federal University of Alagoas, Maceió, AL, Brazil

http://orcid.org/0000-0001-9748-5830

Correspondence: Valdeci Elias dos Santos Júnior, Department of Pediatric Dentistry, School of Dentistry, Federal University of Alagoas, Rua Lourival Melo Mota, S/N, Tabuleiro do Martins, Maceió, AL, Brazil. E-mail:valdeciodonto@gmail.com

Conflict of Interest

The authors declare no conflicts of interest.

Author	Year	Sample/Age	Type of Study	Groups	Results Primary Outcome	Results Secondary Outcome	Assessment Scale	Conclusion
Lima et al. [¹⁰[10] Lima AR, da Costa LR, da Costa PS. A randomized, controlled, crossover trial of oral midazolam and hydroxyzine for pediatric dental sedation. Pesqui Odontol Bras 2003; 17(3):206-11. https://doi.org/10.1590/s1517-74912003000300002 https://doi.org/10.1590/s1517-7491200300... ]	2003	11 children	Controlled, crossover and double-blind clinical trial.	Group 1: Placebo (P)	The overall behavioral analysis showed that group M presented significantly better results than groups (P) and (MH). The success rates for each group only taking into account general scores for satisfactory behavioral management were 7.7% (P), 77.0% (M) and 30.8% (MH). Group M showed better and more statistically significant results when compared to group P (p=0.011) and MH (p=0.022).	No adverse reaction was observed and/or reported in the study during the sessions.	The behavioral assessment was based on the behavioral rating scale proposed by Houpt.	The MH group presented sleepiness at the beginning of the sessions. The overall behavior was better in (M) than in (P) and (MH). Group (M) was effective and safe, while the combination (MH) did not lead to significant advantages for pediatric dentistry sedation.
Shapira et al. [¹¹[11] Shapira J, Kupietzky A, Kadari A, Fuks AB, Holan G. Comparison of oral midazolam with and without hydroxyzine in the sedation of pediatric dental patients. Pediatr Dent 2004; 26(6):492-6.]	2004	28 children (21 to 56 months old)	Controlled, crossover and double-blind clinical trial.	Group 1: Midazolam (M) [M = 0.5 mg/kg] Group 2: Midazolam (M) and Hydroxyzine (H) [M = 0.3 mg/kg, combined with H = 3.7 mg/kg].	Regarding the effectiveness of sedation in the overall behavioral analysis, both regimes presented a 75% success rate. Therefore, no statistically significant difference was observed amongst the groups (p=0.518)	No adverse reaction was observed and/or reported in the study during the sessions.	A modified version of the behavioral scale from Ohio State University was used, as well as the scale proposed by Houpt.	Both approaches are effective for sedation. However, the use of Midazolam as a sedative drug is recommended for short dental procedures, with its combined use with hydroxyzine being recommended for longer procedures.

Studies	Domains
Studies	1	2	3	4	5	Overall
Lima et al. [¹⁰[10] Lima AR, da Costa LR, da Costa PS. A randomized, controlled, crossover trial of oral midazolam and hydroxyzine for pediatric dental sedation. Pesqui Odontol Bras 2003; 17(3):206-11. https://doi.org/10.1590/s1517-74912003000300002 https://doi.org/10.1590/s1517-7491200300... ]	-	?	+	-	+	-
Shapira et al. [¹¹[11] Shapira J, Kupietzky A, Kadari A, Fuks AB, Holan G. Comparison of oral midazolam with and without hydroxyzine in the sedation of pediatric dental patients. Pediatr Dent 2004; 26(6):492-6.]	+	?	+	-	+	-

Question: For oral sedation in children, is the combined use of midazolam and hydroxyzine more effective than midazolam as monotherapy? Quality analysis by GRADE. Context: Oral sedation effectiveness in children in dental setting.
Number of studies	Design	Limitations	Inconsistency	Indirectness	Imprecision	Other considerations	Quality
Outcome: Oral Sedation Effectiveness
2 (39 children)	Crossover Clinical Trial	Serious limitations¹	Serious inconsistencies²	No serious indirectness	Serious imprecision³	None	Very Low

[1] Correspondence: Valdeci Elias dos Santos Júnior, Department of Pediatric Dentistry, School of Dentistry, Federal University of Alagoas, Rua Lourival Melo Mota, S/N, Tabuleiro do Martins, Maceió, AL, Brazil. E-mail:valdeciodonto@gmail.com

Brasil

Brasil

Efficacy and Safety of Oral Midazolam Sedation Compared with its Combination with Hydroxyzine Use in Pediatric Dentistry: A Systematic Review

ABSTRACT

Objective:

Material and Methods:

Results:

Conclusion: