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A paediatric trial comparing midazolam/Syrpalta mixture with premixed midazolam syrup (Roche)
Samia N Khalil1, H N Vije, S S Kee
1Department of Anesthesiology, The University of Texas Medical School at Houston, Houston, TX, USA. Samia.N.Khalil@uth.tmc.edu
Paediatric Anaesthesia
|March 19, 2003
Summary
The midazolam/Syrpalta grape syrup mixture provides faster sedation and reduces anxiety in children compared to a premixed cherry-flavored midazolam solution. This finding is crucial for pediatric procedural sedation.
Area of Science:
- Pediatric Anesthesiology
- Pharmacology
- Clinical Trial Research
Background:
- Midazolam's bitter taste can be masked by mixing with palatable vehicles like fruit juice or syrup for pediatric use.
- A grape syrup (Syrpalta) mixture resulted in rapid sedation (10-15 min), contrasting with an observed slower onset for a premixed cherry-flavored midazolam solution.
- The study aimed to compare the efficacy of these two midazolam preparations in pediatric patients.
Purpose of the Study:
- To evaluate the onset of action of midazolam when mixed with grape syrup (Syrpalta) versus a premixed cherry-flavored solution.
- To assess the impact of these midazolam mixtures on children's anxiety, sedation levels, separation anxiety, mask acceptance, and recovery time.
- To determine the optimal formulation for pediatric premedication to improve patient experience and procedural efficiency.
Main Methods:
- A double-blind, randomized trial involving 76 healthy children aged 1-4 years undergoing elective ear tube placement.
- Participants received either the premixed midazolam or the midazolam/Syrpalta mixture for premedication.
- An independent observer used standardized scales to assess anxiety, sedation, mask acceptance, and awakening time at various intervals.
Main Results:
- The midazolam/Syrpalta mixture group exhibited significantly reduced anxiety at 15 minutes post-administration and upon parental separation compared to the premixed solution (P = 0.046 and P < 0.001, respectively).
- No significant difference was observed in mask acceptance between the two groups.
- These results suggest a more rapid onset of sedative and anxiolytic effects with the Syrpalta mixture.
Conclusions:
- The midazolam/Syrpalta mixture demonstrates a faster onset of action compared to the premixed midazolam solution.
- This grape syrup formulation appears more effective in mitigating pre-procedural anxiety in young children.
- The findings support the use of the midazolam/Syrpalta mixture for improved pediatric procedural sedation.