Non-Cochrane · intervention · PM42445150
Intranasal dexmedetomidine versus midazolam for pediatric dental sedation: a pooled analysis of clinical trials.
Lyu Jingyan, Yu Cong, Li Sisi, et al. · Frontiers in medicine · 2026 · PubMed · doi:10.3389/fmed.2026.1882122
Findings
Population Children aged 1 to 14 years undergoing dental procedures
12 findings
| Intranasal dexmedetomidine | Intranasal midazolam | Onset time (min) Pediatric dental procedures | MD 8.79 [6.70, 10.87] Moderate Downgraded: risk of bias 4 studies · 207 participants |
| Intranasal dexmedetomidine | Intranasal midazolam | Procedure success rate Pediatric dental procedures | RR 1.29 [0.86, 1.94] Low Downgraded: imprecision, inconsistency 3 studies · 131 participants |
| Intranasal dexmedetomidine | Intranasal midazolam | Satisfactory behavior rate Pediatric dental procedures | RR 1.21 [0.94, 1.56] Moderate Downgraded: imprecision 2 studies · 83 participants |
| Intranasal dexmedetomidine | Intranasal midazolam | Satisfactory sedation rate Pediatric dental procedures | RR 1.04 [0.92, 1.16] Moderate Downgraded: imprecision 3 studies · 131 participants |
| Intranasal sedation regimens | Oral sedation regimens (midazolam-based) | Procedure success rate Pediatric dental procedures | RR 1.07 [0.99, 1.16] Moderate Downgraded: imprecision 2 studies · 167 participants |
| Intranasal sedation regimens | Oral sedation regimens (midazolam-based) | Adverse events Pediatric dental procedures | RR 0.93 [0.51, 1.72] Moderate Downgraded: imprecision 2 studies · 167 participants |
| Intranasal sedation regimens | Oral sedation regimens (midazolam-based) | Satisfactory sedation rate Pediatric dental procedures | RR 4.41 [0.32, 60.04] Very low Downgraded: risk of bias, imprecision, inconsistency 2 studies · 127 participants |
| Intranasal sedation regimens | Oral sedation regimens (midazolam-based) | Satisfactory behavior rate Pediatric dental procedures | RR 1.97 [0.76, 5.14] Very low Downgraded: risk of bias, imprecision, inconsistency 2 studies · 128 participants |
| Intranasal sedation regimens | Oral sedation regimens (midazolam-based) | Onset time (min) Pediatric dental procedures | MD -15.17 [-49.26, 18.92] Low Downgraded: imprecision, inconsistency 2 studies · 127 participants |
| Combined intranasal regimens | Single intranasal agents | Onset time (min) Pediatric dental procedures | MD -3.68 [-8.72, 1.36] Low Downgraded: imprecision, inconsistency 2 studies · 160 participants |
| Combined intranasal regimens | Single intranasal agents | Satisfactory sedation rate Pediatric dental procedures | RR 0.98 [0.91, 1.04] Moderate Downgraded: imprecision 2 studies · 160 participants |
| Combined intranasal regimens | Single intranasal agents | Procedure success rate Pediatric dental procedures | RR 1.25 [0.73, 2.13] Low Downgraded: imprecision, inconsistency 2 studies · 160 participants |
Included primary studies 17
Open in Studies| Study | Year | Also included by | Outcomes it informs here | Trial data |
|---|---|---|---|---|
| Surendar 2014 A comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind… PMID:25095322 | 2014 | 1 other review | not stated | not extracted yet |
| Agarwal 2023 Comparative evaluation of intranasal midazolam-ketamine, dexmedetomidine-ketamine, midazolam-fentanyl, and dexmedetomidine-fentanyl… PMID:37034838 | 2023 | this review only | not stated | not extracted yet |
| Arnaout 2025 Evaluation of the Efficacy of Buccal Midazolam in Comparison With Intranasal Midazolam Sedation in Uncooperative Children During Dental… PMID:40130021 | 2025 | this review only | not stated | not extracted yet |
| Chang 2023 Comparison of sedative effects of intramuscular and intranasal midazolam for pediatric laceration repair in dental emergency department: A… PMID:36707049 | 2023 | this review only | not stated | not extracted yet |
| Elkhatib 2024 (1) Sedative and behavioral effects of atomized intranasal midazolam in comparison with nebulized midazolam for children undergoing dental… PMID:39256918 | 2025 | this review only | not stated | not extracted yet |
| Elkhatib 2024 (1) Effect of Dexmedetomidine with or without Midazolam during procedural dental sedation in children: a randomized controlled clinical trial. PMID:39462365 | 2024 | this review only | not stated | not extracted yet |
| Hamod 2022 Evaluation of the Efficacy of Nasal Sedation Midazolam Compared with Dexmedetomidine in the Management of Uncooperative Children with Down… PMID:36160114 | 2022 | this review only | not stated | not extracted yet |
| Hitt 2014 An evaluation of intranasal sufentanil and dexmedetomidine for pediatric dental sedation. PMID:24662315 | 2014 | this review only | not stated | not extracted yet |
| Lalwani 2025 Comparative evaluation of the effectiveness and acceptance of intranasal dexmedetomidine and intranasal midazolam for sedation in children… PMID:40201232 | 2025 | this review only | not stated | not extracted yet |
| Malhotra 2016 Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: A double-blinded… PMID:27307665 | 2016 | this review only | not stated | not extracted yet |
| Nie 2023 Oral midazolam vs. intranasal dexmedetomidine plus oral midazolam for sedation of pediatric outpatients: a double-blinded randomized… PMID:37817075 | 2023 | this review only | not stated | not extracted yet |
| Patel 2018 A comparative assessment of intranasal and oral dexmedetomidine for procedural sedation in pediatric dental patients. PMID:30324927 | 2018 | this review only | not stated | not extracted yet |
| Peerbhay 2016 Intranasal Midazolam Sedation in a Pediatric Emergency Dental Clinic. PMID:27585415 | 2016 | this review only | not stated | not extracted yet |
| Sado-Filho 2019 Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient… PMID:30856181 | 2019 | this review only | not stated | not extracted yet |
| Sado-Filho 2021 Intranasal Dexmedetomidine Compared to a Combination of Intranasal Dexmedetomidine with Ketamine for Sedation of Children Requiring Dental… PMID:34199001 | 2021 | this review only | not stated | not extracted yet |
| Wang 2023 Intranasal esketamine combined with oral midazolam provides adequate sedation for outpatient pediatric dental procedures: a prospective… PMID:37288546 | 2023 | this review only | not stated | not extracted yet |
| Xin 2021 Comparison between dexmedetomidine and esketamine in pediatric dentistry surgery. PMID:35070829 | 2021 | this review only | not stated | not extracted yet |
Overlap with other reviews
Reviews that include the same primary studies are not independent evidence. Shared counts match studies by PMID, DOI or NCT, and otherwise by author and year (a probable match). Only the non-Cochrane dental reviews have study lists, so overlap with Cochrane reviews is not counted yet.
| Review | Shared studies | Jaccard |
|---|---|---|
| The Efficacy of Dexmedetomidine Versus Ketamine for Sedation in Pediatric Dental Procedures: A Systematic Review and Meta-Analysis. (2026) | 1 | 0.05 |
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Children under 18 years, ASA I or II, needing dental treatment with non-cooperation, anxiety or severe phobia | 1,215 children aged 1 to 14 years (17 studies) |
| Intervention | Intranasal sedation with single or combined sedative agents | Intranasal midazolam (8 studies), intranasal dexmedetomidine (9), oral sedatives (4), combined intranasal regimens (7) |
| Comparison | Placebo, oral sedation regimens or an alternative intranasal sedation regimen | Intranasal midazolam, oral midazolam-based regimens, single intranasal agents |
| Outcomes | Primary: procedure success rate. Secondary: onset time, sedation duration, satisfactory sedation rate, satisfactory behavior rate, adverse events | Procedure success rate, onset time, sedation duration, satisfactory sedation rate, satisfactory behavior rate, adverse events |
| Study designs | Parallel-group RCTs and non-randomized studies, English language, 2014 to 2025; cross-over trials excluded | 15 RCTs and 2 non-randomized studies; pooled estimates from RCTs only |
| Timing | Not specified | Not specified |
AMSTAR 2 items
Two independent extractors rated each item. Their ratings are shown side by side because they have not been reconciled yet. The overall rating follows Shea et al. 2017: one critical flaw gives Low, more than one gives Critically Low.
| Item | Extractor A | Extractor B | Agree |
|---|---|---|---|
| 1Research question includes PICO components | Yes | Yes | yes |
| 2Protocol established before the reviewcritical | Partial Yes | Partial Yes | yes |
| 3Choice of study designs explained | No | Yes | no |
| 4Comprehensive literature searchcritical | Partial Yes | Partial Yes | yes |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | Yes | Yes | yes |
| 7List of excluded studies with reasonscritical | No | No | yes |
| 8Included studies described in detail | Partial Yes | Partial Yes | yes |
| 9Risk of bias assessed satisfactorilycritical | RCT: Yes · NRSI: Yes | NRSI: Yes · RCT: Yes | no |
| 10Funding of included studies reported | No | No | yes |
| 11Appropriate meta-analysis methodscritical | RCT: No · NRSI: N/A | NRSI: N/A · RCT: Yes | no |
| 12Impact of risk of bias on the pooled results | No | No | yes |
| 13Risk of bias accounted for in interpretationcritical | Yes | Yes | yes |
| 14Heterogeneity explained | Yes | Yes | yes |
| 15Publication bias investigatedcritical | No | No | yes |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Critically Low | Critically Low | yes |