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

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ClinicalTrials.gov Identifier: NCT00634374
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : April 14, 2008
Sponsor:
Information provided by:
Bronx-Lebanon Hospital Center Health Care System

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.


Condition or disease Intervention/treatment Phase
Infant Acceptance of Medication Device: Rx Medibottle Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Start Date : January 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Infant acceptance of the bitter-tasting oral liquid medication [ Time Frame: On the day of enrollment, with use of drug delivery device ]

Secondary Outcome Measures :
  1. Time needed to administer medication using the drug delivery method [ Time Frame: Measured at the time of drug administration by stopwatch ]
  2. Maternal satisfaction with drug delivery method [ Time Frame: At the time of administration or on viewing a videotape of administration ]
  3. 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 ]


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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634374


Locations
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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
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Principal Investigator: Murli U Purswani, MD Bronx-Lebanon Hospital Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. M Purswani and Dr. J Radhakrishnan, Bronx-Lebanon Hospital Center
ClinicalTrials.gov Identifier: NCT00634374     History of Changes
Other Study ID Numbers: 09090405
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: April 14, 2008
Last Verified: March 2008
Keywords provided by Bronx-Lebanon Hospital Center Health Care System:
Rx medibottle
Oral syringe
Liquid medication
Bitter-tasting
Infants