Journal of Research in Dental
and Maxillofacial Sciences
Volume 10, Issue 4 (12-2025)
J Res Dent Maxillofac Sci 2025, 10(4): 310-320 |
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Ethics code: IR.SBMU.DRC.REC.1399.131
Clinical trials code: 20211123053154N1
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Esmaeilzadeh M, Eghbali A, Ansari G, Fallahinejad Ghajari M, Soleymani A, Yavarifar J et al . Efficacy of Intravenous Propofol-Fentanyl versus Ketamine-Midazolam Combinations for Procedural Sedation of Uncooperative 2-6 Year-Old Pediatric Dental Patients: A Randomized Clinical Trial. J Res Dent Maxillofac Sci 2025; 10 (4) :310-320
URL: http://jrdms.dentaliau.ac.ir/article-1-738-en.html
URL: http://jrdms.dentaliau.ac.ir/article-1-738-en.html
Mohammad Esmaeilzadeh1 
, Ahmad Eghbali2 , Ghassem Ansari1 , Masoud Fallahinejad Ghajari1 , Ali Soleymani1 , Jina Yavarifar3 , Leila Eftekhar *4
, Ahmad Eghbali2 , Ghassem Ansari1 , Masoud Fallahinejad Ghajari1 , Ali Soleymani1 , Jina Yavarifar3 , Leila Eftekhar *4
1- Department of Pediatric Dentistry, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
2- Anesthesiology Research Center, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3- Private Dentistry Practice, Tehran, Iran
4- Department of Pediatric Dentistry, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran. ,leila.eftekhar.a@gmail.com
2- Anesthesiology Research Center, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3- Private Dentistry Practice, Tehran, Iran
4- Department of Pediatric Dentistry, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran. ,
Abstract: (8 Views)
Background and Aim: This study aimed to evaluate the efficacy and safety of intravenous propofol-fentanyl versus ketamine-midazolam combinations for sedation of 2-6-year-old uncooperative dental patients.
Materials and Methods: This triple-blind crossover randomized clinical trial included 24 (13 boys and 11 girls) healthy (ASA I) uncooperative (Frankl I) 2-6-year-old (mean age: 3.7±1.1 years) children who were randomly divided into two groups. The first group (AB) received intravenous propofol (2 mg/kg) in addition to fentanyl (1 µg/kg) in the first session and ketamine (2 mg/kg) along with midazolam (0.2 mg/kg) in the second session. The second group (BA) received the two drug combinations in a reverse order to allow testing the potential sequence effect. Oral midazolam (0.3 mg/kg) was administered as premedication. Changes in hemodynamic indices and reactions to dental stimulations were recorded using the monitoring device and Houpt scale, respectively. Data were analyzed using the Pearson Chi-Square test, independent t-test, and Mann-Whitney U test (alpha=0.05).
Results: There were no significant differences in hemodynamic indices, namely the SpO2 (P=0.179) and heart rate (HR) (P=0.062), and overall behavior (P=0.378) of the two groups during the treatment phases, including catheter insertion, local anesthetic injection, and at 15 and 30 minutes following the onset of dental treatment. However, the recovery time was significantly longer in the ketamine-midazolam than the propofol-fentanyl group (P=0.00).
Conclusion: Based on the results of this study, the use of propofol-fentanyl combination for behavioral control of uncooperative children provided better sedation quality and scores, and lower hemodynamic changes compared to ketamine-midazolam, although this difference was not statistically significant.
Materials and Methods: This triple-blind crossover randomized clinical trial included 24 (13 boys and 11 girls) healthy (ASA I) uncooperative (Frankl I) 2-6-year-old (mean age: 3.7±1.1 years) children who were randomly divided into two groups. The first group (AB) received intravenous propofol (2 mg/kg) in addition to fentanyl (1 µg/kg) in the first session and ketamine (2 mg/kg) along with midazolam (0.2 mg/kg) in the second session. The second group (BA) received the two drug combinations in a reverse order to allow testing the potential sequence effect. Oral midazolam (0.3 mg/kg) was administered as premedication. Changes in hemodynamic indices and reactions to dental stimulations were recorded using the monitoring device and Houpt scale, respectively. Data were analyzed using the Pearson Chi-Square test, independent t-test, and Mann-Whitney U test (alpha=0.05).
Results: There were no significant differences in hemodynamic indices, namely the SpO2 (P=0.179) and heart rate (HR) (P=0.062), and overall behavior (P=0.378) of the two groups during the treatment phases, including catheter insertion, local anesthetic injection, and at 15 and 30 minutes following the onset of dental treatment. However, the recovery time was significantly longer in the ketamine-midazolam than the propofol-fentanyl group (P=0.00).
Conclusion: Based on the results of this study, the use of propofol-fentanyl combination for behavioral control of uncooperative children provided better sedation quality and scores, and lower hemodynamic changes compared to ketamine-midazolam, although this difference was not statistically significant.
Type of Study: Original article |
Subject:
pediatric
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