Hemodynamic changes in third molar exodontia using, orally, midazolam versus diazepam: a systematic review of randomized clinical trials

Silva, Janielma Azevedo; Souza Junior, Erasmo Freitas de; Andrade, Micássio Fernandes de; Morais, Hécio Henrique Araújo de

doi:10.1590/1981-86372025000120240001

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REVIEW • Rev Gaúch. Odontol. 73 • 2025 • https://doi.org/10.1590/1981-86372025000120240001 linkcopy

Hemodynamic changes in third molar exodontia using, orally, midazolam versus diazepam: a systematic review of randomized clinical trials

Alterações hemodinâmicas em exodontia de terceiro molar utilizando, por via oral, midazolam versus diazepam: uma revisão sistemática de ensaios clínicos randomizados

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Objective: Compare the effect of Diazepam versus Midazolam on hemodynamic changes in oral conscious sedation in lower third molar exodontias.

Methods: A systematic review was conducted, with registration in the International Prospective Register of Systematic Reviews (protocol CRD42020162953), using the databases from PubMed/MEDLINE, Embase, Cochrane Library, BVS Regional Portal and Grey Literature (Clinical Trial and OpenGrey), and also manual searches in Bucomaxillofacial Surgery journals, concluding the collections on November 3, 2020, updated on September 20, 2024. Randomized clinical trials comparing Diazepam with Midazolam were included, excluding those with incomplete information, which did not assess blood pressure, heart rate and peripheral oxygen saturation, and those which texts were not located. A risk of bias analysis was performed using the RoB 2.0 Cochrane Handbook for Systematic Reviews of Interventions tool. Subsequently, a narrative synthesis was conducted to show the results.

Results: From the 2,017 records found, only two were included, aggregating 210 patients. Midazolam showed better results in blood pressure and peripheral oxygen saturation, while Diazepam showed more favorable values in heart rate.

Conclusion: Due to limitations such as absence of data and failures in randomization, the evidences were considered fragile, requiring further randomized clinical trials, with a better scientific design.

Indexing terms
Conscious sedation; Diazepam; Midazolam; Systematic review; Third molar

SUMMARY OF INCLUDED STUDIES CHARACTERISTICS
Author/ Year	Country of origin	Study type	n	Conducted procedures	Interventions / controls	Presentation/Route	Variables of interest
Morais et al. [⁷]	Brazil	Paper published in a journal	120	Exodontias of upper and lower third molars	Diazepam 10 mg x Placebo; Midazolam 7.5 mg x Placebo; Midazolam 7.5 mg x Diazepam 10mg	Tablet/ Oral	BP; HR; SpO₂; Pressure rate product and Pressure rate quotient
Chaia [¹⁶]	Brazil	Doctoral thesis	120	Exodontias of upper and lower third molars	Diazepam 10mg; Midazolam 15mg; Bromazepam 6mg; No drug	Tablet/ Oral	BP; HF and SpO₂

Sample characteristics and groups distribution
Groups	n	%	Age (mean / standard deviation)
Diazepam 10mg x Placebo (G1)*	40	19.0	22.7 ± 6.2
Midazolam 7.5mg x Placebo (G2)*	40	19.0	22.8 ± 3.4
Midazolam 7.5mg x Diazepam 10mg (G3)*	40	19.0	23.1 ± 5.3
Diazepam 10mg (GI)**	30	14.3	25#
Midazolam 15mg (GIII)**	30	14.3	22.7#
No medication (GIV)**	30	14.3	22.2#
Total	210	100

Results with statistically significant differences
Variables			Comparisons	Comparisons moments			Mean values
Blood pressure p<0.05	Systolic blood pressure	Midazolam 15mg x No Drug or Placebo (NDP)			Mean of different moments (MDM)	Diazepam 10mg (135.27 mmHg); NDP (137.94 mmHg); Midazolam 15mg (126.16 mmHg).
	Systolic blood pressure	Midazolam 15mg x diazepam 10mg			MDM
	Diastolic blood pressure	Midazolam 15mg x NDP			MDM	NDP (81.70 mmHg); Diazepam 10mg (80.77 mmHg); Midazolam 15mg (72.66 mmHg). Midazolam 7.5mg with lower values compared to Diazepam 10mg^a.
		Midazolam 15mg x diazepam 10mg^b			MDM
		Midazolam 7.5mg x diazepam 10mg^a			10 min after anesthesia administration and at the end of the surgical procedure
Heart rate p<0.05		Midazolam 7,5mg^a x placebo			5 and 10 min after anesthesia administration	Higher rates in those who used midazolam^a;b.
Heart rate p<0.05		Midazolam 7.5mgb x diazepam 10mg			10 min after anesthesia administration	Higher rates in those who used midazolam^a;b.
Peripheral oxygen saturation p<0.05		Diazepam 10 mg x midazolam 15mg			MDM	Diazepam 10 mg (97%); Midazolam 15mg (99%); MNE (92%).
		NDP x Diazepam 10 mg			MDM
		NDP x midazolam 15mg			MDM

Results With No Statistically Significant Differences
Blood pressure	A p>0.05 was found when comparing systolic BP of G1, G2 and G3, during the clinical examination (T0), immediately before anesthesia (T1), 5 min after anesthesia administration (T2), 10 min after anesthesia administration (T3) and at the end of the surgical procedure (T4). A p>0.05 was also observed when comparing the diastolic BP of G1 and G2 in T0, T1, T2, T3 and T4, when comparing the values of G3 in T0, T1 and T2, when comparing GI with GIV.
Heart rate	A p>0.05 was found when comparing the HR of G1 in T0, T1, T2, T3 and T4, of G2 in T0, T1 and T4, of G3 in T0, T1, T2 and T4. There were also no statistical differences when comparing MDM between GI, GIII and GIV groups.
Peripheral oxygen saturation	A p>0.05 was found when comparing the means in groups G1, G2 and G3 in T0, T1, T2, T3 and T4.

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[1] Note:

[TFN01] ^*
Study of Morais et al.¹³;

[TFN02] ^**
Study of Chaia¹⁶;

[TFN03] ^#
Standard deviation not available.