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

NCT00634374 | Completed

• 1 other identifier: 09090405
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Acceptance of Medication

Keywords

Rx medibottle; Oral syringe; Liquid medication; Bitter-tasting; Infants

Outcome Measures

Primary Outcomes (1)

• Infant acceptance of the bitter-tasting oral liquid medication

  On the day of enrollment, with use of drug delivery device

Secondary Outcomes (3)

• Time needed to administer medication using the drug delivery method

  Measured at the time of drug administration by stopwatch

• Maternal satisfaction with drug delivery method

  At the time of administration or on viewing a videotape of administration

• Administration of the entire dose of medication with each drug delivery method

  On the day of enrollment, with use of drug delivery device

Study Arms (2)

1

NO INTERVENTION

Oral Syringe

2

ACTIVE COMPARATOR

Rx medibottle

Device: Rx Medibottle

Interventions

Rx Medibottle DEVICE

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

2

Eligibility Criteria

• Age: 2 Days - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Admitted to the pediatric inpatient unit
• Stable condition
• Bottle fed
• Less than 2 years
• Receiving prednisolone syrup (15 mg/5 ml)

You may not qualify if:

• Breast fed
• Greater than 2 years

Sponsors & Collaborators

• Bronx-Lebanon Hospital Center Health Care System: lead

Study Sites (1)

Bronx-Lebanon Hospital Center

The Bronx, New York, 10457, United States

Location

Related Publications (1)

• 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.

  PMID: 19188654 DERIVED

Study Officials

• Murli U Purswani, MD

  Bronx-Lebanon Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 13, 2008
• Study Start: January 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: April 14, 2008

Record last verified: 2008-03

Locations

US (1)