Bronx-Lebanon Hospital Center
The Bronx, New York, 10457, United States
Completed
NCT Number: NCT00634374
Administration of a Bitter-Tasting Medication: Comparison Between the Rx Medibottle and the Oral Syringe
Hypothesis: The Rx medibottle is more effective than the oral syringe when giving infants less than 2 years of age a bitter-tasting medication (prednisolone syrup).
Summary: Infants who were admitted to the pediatric floor with a respiratory illness at the Bronx-Lebanon Hospital were offered the chance to take part in the study. If these children needed prednisolone syrup for their treatment, were less than 2 years old and were bottle-fed, and were in stable condition, they qualified. They were randomly assigned (just by chance), into a control arm, where they received medication using the oral syringe, or an intervention arm, where they were given medication using the Rx medibottle. How well the infant accepted the bitter-tasting medication was compared between the two arms using an infant medication acceptance scale. The scale was administered and a score generated by two raters: the nurse who administered the medication, and a child life therapist who witnessed the administration. The time needed to give the medication, the drug delivery device's ability to administer the entire dose of medication and the mother's satisfaction with the method used were also compared between the two arms.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
2 day–24 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
The ability to deliver drugs to infants and children safely and accurately has long been of concern to pediatricians and caregivers. Calibrated oral syringes are accurate in measuring and delivering the required dose, have minimal potential for spillage and are considered the standard drug delivery system for this population. However, infant acceptance of the syringe may not always be favorable. The objective of this study was to compare the Rx medibottle to the oral syringe when used to administer liquid medication to infants. It is a prospective, controlled trial that enrolled infants <2 years of age admitted to a community hospital in the Bronx, who were prescribed a daily dose of 2 mg/kg of prednisolone syrup (15 mg/5 ml) for a respiratory illness. Participants were randomly assigned to receive one dose of prednisolone syrup using the Rx medibottle (intervention arm) or the oral syringe (control arm). The infant medication acceptance scale (MAS) used to evaluate acceptance by the infants was developed and validated by Donna Kraus, Leslie Stohlmeyer and Patricia Hannon and published in the American Journal of Health-System Pharmacy (1999;16:1094-1101).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Admitted to the pediatric inpatient unit
- Stable condition
- Bottle fed
- Less than 2 years
- Receiving prednisolone syrup (15 mg/5 ml)
Exclusion criteria
- Breast fed
- Greater than 2 years
Treatment and study plan
Rx Medibottle
DeviceComparing use of the Rx medibottle to the oral syringe in delivering a one-time dose of prednisolone syrup
Primary outcomes
-
Infant acceptance of the bitter-tasting oral liquid medication
Time frame: On the day of enrollment, with use of drug delivery device
Secondary outcomes
-
Time needed to administer medication using the drug delivery method
Time frame: Measured at the time of drug administration by stopwatch
-
Maternal satisfaction with drug delivery method
Time frame: At the time of administration or on viewing a videotape of administration
-
Administration of the entire dose of medication with each drug delivery method
Time frame: On the day of enrollment, with use of drug delivery device
Sponsors and collaborators
Lead sponsor
Bronx-Lebanon Hospital Center Health Care System
Other
Registry information
Official study title
Efficacy of the Rx Medibottle Compared to the Oral Syringe in Delivering Infant-Acceptable Liquid Medication Completely and Accurately: a Controlled Clinical Trial
Important dates
- Study start
- 2005
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Mar 13, 2008
- Registry last updated
- Apr 14, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.