Administration of a Bitter-Tasting Medication: Comparison Between the Rx Medibottle and the Oral Syringe - Full Text View

Sponsored by:	Bronx-Lebanon Hospital Center Health Care System
Information provided by:	Bronx-Lebanon Hospital Center Health Care System
ClinicalTrials.gov Identifier:	NCT00634374

Purpose

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.

Condition	Intervention
Infant Acceptance of Medication	Device: Rx Medibottle

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Taste and Smell Disorders

U.S. FDA Resources

Further study details as provided by Bronx-Lebanon Hospital Center Health Care System:

Primary Outcome Measures:

Infant acceptance of the bitter-tasting oral liquid medication [ Time Frame: On the day of enrollment, with use of drug delivery device ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time needed to administer medication using the drug delivery method [ Time Frame: Measured at the time of drug administration by stopwatch ] [ Designated as safety issue: No ]
Maternal satisfaction with drug delivery method [ Time Frame: At the time of administration or on viewing a videotape of administration ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	81
Study Start Date:	January 2005
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Oral Syringe
2: Active Comparator Rx medibottle	Device: Rx Medibottle Comparing use of the Rx medibottle to the oral syringe in delivering a one-time dose of prednisolone syrup

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

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634374

Locations

United States, New York
Bronx-Lebanon Hospital Center
Bronx, New York, United States, 10457

Sponsors and Collaborators

Bronx-Lebanon Hospital Center Health Care System

Investigators

Principal Investigator:

Murli U Purswani, MD

Bronx-Lebanon Hospital Center

More Information

No publications provided by Bronx-Lebanon Hospital Center Health Care System

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Bronx-Lebanon Hospital Center ( Dr. M Purswani and Dr. J Radhakrishnan )
Study ID Numbers:	09090405
Study First Received:	February 25, 2008
Last Updated:	April 11, 2008
ClinicalTrials.gov Identifier:	NCT00634374 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Bronx-Lebanon Hospital Center Health Care System:

Rx medibottle
Oral syringe
Liquid medication
Bitter-tasting
Infants

Study placed in the following topic categories:

Methylprednisolone
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone Hemisuccinate

ClinicalTrials.gov processed this record on September 10, 2009