Clinical trial NCT00634374: Administration of a Bitter-Tasting Medication: Comparison Between the Rx Medibottle and the Oral Syringe
Official title: Efficacy of the Rx Medibottle Compared to the Oral Syringe in Delivering Infant-Acceptable Liquid Medication Completely and Accurately: a Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Acceptance of Medication
Keywords: Rx medibottle
Oral syringe
Liquid medication
Bitter-tasting
Infants
Lead sponsor: Bronx-Lebanon Hospital Center Health Care System
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 81
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Infant acceptance of the bitter-tasting oral liquid medication
timeFrame: On the day of enrollment, with use of drug delivery device
Secondary outcomes:
measure: Time needed to administer medication using the drug delivery method
timeFrame: Measured at the time of drug administration by stopwatch
measure: Maternal satisfaction with drug delivery method
timeFrame: At the time of administration or on viewing a videotape of administration
measure: Administration of the entire dose of medication with each drug delivery method
timeFrame: On the day of enrollment, with use of drug delivery device
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital Center
state: New York
Study officials:
affiliation: Bronx-Lebanon Hospital Center
name: Murli U Purswani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Purswani MU, Radhakrishnan J, Irfan KR, Walter-Glickman C, Hagmann S, Neugebauer R. Infant acceptance of a bitter-tasting liquid medication: a randomized controlled trial comparing the Rx Medibottle with an oral syringe. Arch Pediatr Adolesc Med. 2009 Feb;163(2):186-8. doi: 10.1001/archpediatrics.2008.541.