Comparative sedative effects of intravenous etomidate/fentanyl/midazolam versus propofol/fentanyl/midazolam combination for dental treatment of uncooperative children: a randomized clinical trial

This study compared the sedative effects of intravenous etomidate/fentanyl/midazolam versus propofol/fentanyl/midazolam combination, with a primary focus on behavioral outcomes assessed by the Houpt scale and hemodynamic safety, for dental treatment of uncooperative children between 3 and 10 years. This patient- and assessor-blinded, crossover clinical trial was conducted on 40 children (27 females, 13 males; mean age, 4.67 ± 1.46 years; mean weight, 15.93 ± 4.2 kg) with negative and very negative behavior, as assessed by the Frankl scale. The children were randomly assigned to 2 groups (n = 20). Group 1 received etomidate (0.2 mg/kg), fentanyl (1 µg/kg), and midazolam (0.2 mg/kg) combination in the first treatment session, and propofol (1 mg/kg), fentanyl (1 µg/kg), and midazolam (0.2 mg/kg) in the second treatment session. This order was reversed in group 2. Hemodynamic indices, including the heart rate (HR) and arterial oxygen saturation (SPO2), were monitored during the procedure, and the behavior of children was recorded using the Houpt behavioral rating scale. Data were analyzed using the Mann-Whitney and t tests (α = 0.05). The hemodynamic indices were within the safe range, with no significant difference between the two groups (P > 0.05). At the time of injection, a statistically significant but clinically modest difference in SPO2 was observed favoring the etomidate group (99.75% vs. 98.85%, P = 0.003); however, mean SPO2 remained above 97% in both groups throughout all procedures. The mean HR showed greater stability with less fluctuation from baseline in the etomidate group compared to propofol (e.g., smaller magnitude of change at injection in the second session, P < 0.005 overall for key time points). The two groups were similar regarding the Houpt scale, except during recovery, where the etomidate group had a significantly higher behavior score (7.45 vs. 6.60, P = 0.007). Both combinations are highly effective and safe for the intravenous sedation of uncooperative children, providing comparable intra-procedural sedation. However, the etomidate/fentanyl/midazolam combination demonstrated specific advantages regarding intra-procedural heart rate stability and more favorable behavioral scores during the recovery period.Trial registration IRCT20230515058193N1, registeredretrospectively on 22 November 2024 in the Iranian Registry of Clinical Trials (https://www.irct.ir/trial/77589).