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Stability of an oral midazolam solution for premedication in paediatric patients
1Department of Pharmacy, Hospital Clínic i Provincial, University of Barcelona, Spain.
Insights
This study confirms the stability and clinical effectiveness of a hospital-prepared oral midazolam solution for pediatric presurgical sedation. The midazolam solution demonstrated no degradation and provided adequate sedation and venous puncture tolerance.
Area of Science:
- Pharmaceutical Sciences
- Pediatric Anesthesiology
Background:
- Oral midazolam is frequently used for presurgical sedation in pediatric patients.
- Ensuring the stability and clinical efficacy of compounded medications is crucial for patient safety and treatment success.
Purpose of the Study:
- To evaluate the chemical stability of a 1 mg/ml oral midazolam solution prepared by a hospital pharmacy.
- To confirm the clinical effectiveness of this midazolam solution in pediatric patients undergoing surgery.
Main Methods:
- Solution stability was assessed by monitoring pH and UV-visible absorption spectra for 60 days at room temperature.
- High-performance liquid chromatography (HPLC) was employed for precise quantification of midazolam.
- Clinical efficacy was evaluated by assessing sedation quality and venous puncture response post-administration (0.3 mg/kg).
Main Results:
- No significant changes in pH were observed in the midazolam solution over the 60-day study period.
- HPLC analysis confirmed no detectable loss of midazolam concentration, indicating excellent stability.
- The oral midazolam solution effectively sedated pediatric patients (n=20, ages 4-7), with good to very good sedation quality and tolerance.
Conclusions:
- The hospital-prepared 1 mg/ml oral midazolam solution is chemically stable for at least 60 days.
- This compounded midazolam formulation is clinically effective for presurgical sedation in pediatric patients, ensuring adequate sedation and tolerance.
- The findings support the routine use of this internally prepared oral midazolam solution in pediatric surgical settings.
Abstract:
The objectives of this study were to assess the stability of a 1 mg/ml oral midazolam solution elaborated by our Hospital Pharmacy Service, and to confirm its clinical effect in presurgical paediatric patients. The solution's stability was tested by determining its pH and its UV-visible absorption spectrum at room temperature for up to 60 days. A high performance liquid chromatography method was used to confirm it. There was no significant change in pH value of either the test or a control solution. No loss of midazolam could be detected during the test. The Anaesthesiology Service assessed the sedation quality (very good, good, bad) and the venous puncture response, 20 minutes after the administration of 0.3 mg/kg of an oral midazolam solution. Twenty children were examined (age: 4-7 years). In addition, the haemodynamic and ventilatory functions were evaluated.