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

NCT ID: NCT00634374

Last Updated: 2008-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-04-30

Brief Summary

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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

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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).

Conditions

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Infant Acceptance of Medication

Keywords

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Rx medibottle Oral syringe Liquid medication Bitter-tasting Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

Oral Syringe

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Rx medibottle

Group Type ACTIVE_COMPARATOR

Rx Medibottle

Intervention Type DEVICE

Comparing use of the Rx medibottle to the oral syringe in delivering a one-time dose of prednisolone syrup

Interventions

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Rx Medibottle

Comparing use of the Rx medibottle to the oral syringe in delivering a one-time dose of prednisolone syrup

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

2 Days

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bronx-Lebanon Hospital Center Health Care System

OTHER

Sponsor Role lead

Responsible Party

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Bronx-Lebanon Hospital Center

Principal Investigators

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Murli U Purswani, MD

Role: PRINCIPAL_INVESTIGATOR

Bronx-Lebanon Hospital Center

Locations

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Bronx-Lebanon Hospital Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 19188654 (View on PubMed)

Other Identifiers

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09090405

Identifier Type: -

Identifier Source: org_study_id