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

April 11, 2008 updated by: Bronx-Lebanon Hospital Center Health Care System

Efficacy of the Rx Medibottle Compared to the Oral Syringe in Delivering Infant-Acceptable Liquid Medication Completely and Accurately: a Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infant acceptance of the bitter-tasting oral liquid medication
Time Frame: On the day of enrollment, with use of drug delivery device
On the day of enrollment, with use of drug delivery device

Secondary Outcome Measures

Outcome Measure
Time Frame
Time needed to administer medication using the drug delivery method
Time Frame: Measured at the time of drug administration by stopwatch
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
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
On the day of enrollment, with use of drug delivery device

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bronx-Lebanon Hospital Center Health Care System

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

April 14, 2008

Last Update Submitted That Met QC Criteria

April 11, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09090405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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