STUDY OBJECTIVE: To compare the effectiveness and infant acceptance of drug delivery of the Rx medibottle with the standard oral syringe. DESIGN: Prospective open-label, randomized, crossover clinical study. SETTING:General pediatric outpatient clinic at an urban university. SUBJECTS:Thirty healthy, bottle-fed infants, aged 2-14 months, receiving routine vaccinations. INTERVENTION: Each infant received a single dose of acetaminophen (Tempra syrup), with one-half delivered by the Rx medibottle and one-half delivered with an oral syringe. MEASUREMENTS AND MAIN RESULTS: Three raters independently evaluated effectiveness and infant acceptance of each drug-delivery device. Effectiveness was based on the percentage of infants receiving 100% of the intended dose. Infant acceptance was scored using a validated infant medication acceptance scale (MAS, 10 = highest level). Significantly more infants received 100% of the intended dose with the Rx medibottle (93.3%) than with the oral syringe (56.7%, p=0.0074). Infants had a significantly higher mean MAS score when using the Rx medibottle (8.3+/-1.8 vs 7.3+/-1.7, p=0.002). In addition, a significantly higher percentage had ideal MAS scores of 9 or above with the Rx medibottle (73%) compared with the oral syringe (17%, p=0.0001). CONCLUSION: The Rx medibottle was more effective and had a higher level of infant acceptance than the oral syringe. Although further studies are necessary, this suggests that the Rx medibottle may be a better method of delivering liquid drug and may increase infant adherence.
RCT Entities:
STUDY OBJECTIVE: To compare the effectiveness and infant acceptance of drug delivery of the Rx medibottle with the standard oral syringe. DESIGN: Prospective open-label, randomized, crossover clinical study. SETTING: General pediatric outpatient clinic at an urban university. SUBJECTS: Thirty healthy, bottle-fed infants, aged 2-14 months, receiving routine vaccinations. INTERVENTION: Each infant received a single dose of acetaminophen (Tempra syrup), with one-half delivered by the Rx medibottle and one-half delivered with an oral syringe. MEASUREMENTS AND MAIN RESULTS: Three raters independently evaluated effectiveness and infant acceptance of each drug-delivery device. Effectiveness was based on the percentage of infants receiving 100% of the intended dose. Infant acceptance was scored using a validated infant medication acceptance scale (MAS, 10 = highest level). Significantly more infants received 100% of the intended dose with the Rx medibottle (93.3%) than with the oral syringe (56.7%, p=0.0074). Infants had a significantly higher mean MAS score when using the Rx medibottle (8.3+/-1.8 vs 7.3+/-1.7, p=0.002). In addition, a significantly higher percentage had ideal MAS scores of 9 or above with the Rx medibottle (73%) compared with the oral syringe (17%, p=0.0001). CONCLUSION: The Rx medibottle was more effective and had a higher level of infant acceptance than the oral syringe. Although further studies are necessary, this suggests that the Rx medibottle may be a better method of delivering liquid drug and may increase infant adherence.
Authors: Matthew W Linakis; Jessica K Roberts; Anita C Lala; Michael G Spigarelli; Natalie J Medlicott; David M Reith; Robert M Ward; Catherine M T Sherwin Journal: Clin Pharmacokinet Date: 2016-02 Impact factor: 6.447