Compliance of uncooperative pediatric patients during ocular prosthesis fabrication with and without Midazolam conscious sedation: a pilot randomized control trial

Purpose Fabrication of ocular prostheses for pediatric patients is often hindered by the lack of patient cooperation. Midazolam conscious sedation could improve compliance of uncooperative pediatric patients and outcomes.Methods This randomized, controlled, triple-blinded trial followed up 96 participants in whom basic behavioral management techniques failed, with a 1:1 allocation to midazolam and placebo groups. The intervention was preceded by a Frankl Behavior rating of the participant, followed by the Wilson et al. and Dental Sedation Teachers Group scales to assess sedation achieved and operating conditions. Evaluators assessed the need for physical restraint, the clinic working environment, prosthetic outcome, and ease-of-procedure parameters for ocular prosthesis fabrication in participants from both groups. The time spent in appointments was also measured. Mean values for the parameters mentioned above were compiled, compared, and analyzed for the placebo and midazolam groups using the chi-square and Mann-Whitney U tests in SPSS.Results While 41.7% of Midazolam group ocular prosthesis appointments had good operating conditions, 87.5% of Placebo group appointments were rated as having poor operating conditions (χ2 = 78.24, p < .001). The mean time spent in appointments was 19.3 minutes shorter for the midazolam group (p < .001). The need for physical restraint was lower, and the prosthetic outcome and ease-of-procedure rating were significantly higher for the midazolam group (p < .001).Conclusions In pediatric patients in whom non-pharmacological behavioral strategies failed, calibrated Midazolam sedation significantly improved clinical outcomes, working environment, and operating conditions during ocular prosthesis fabrication.