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To Evaluate the Paediatric Analgesia Slide

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by County Durham and Darlington NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00765609
First Posted: October 3, 2008
Last Update Posted: October 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
County Durham and Darlington NHS Foundation Trust
  Purpose

The Paediatric Analgesia Slide is a device developed for parents. Its development follows research into the Paediatric Analgesia Wheel, a device intended for use by hospital doctors. Previous research has shown the benefit of using aids such as the Paediatric Analgesia Wheel when simulating prescribing to children in hospital.

At present, it is unknown whether this concept can be extended to use by parents when administering paracetamol to their children at home.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: To Evaluate the Paediatric Analgesia Slide, a New Device Developed to Assist Parents in Administering Paracetamol to Children at Home

Resource links provided by NLM:


Further study details as provided by County Durham and Darlington NHS Foundation Trust:

Primary Outcome Measures:
  • Comparison of prescription accuracy using the information distributed with over−the−counter medication with the new device [ Time Frame: at data analysis ]

Secondary Outcome Measures:
  • Ability of parents to interpret the prescribing information related to minimum dosage interval and maximum dosage frequency [ Time Frame: at data analysis ]
  • To assess whether parents can accurately draw up the volume that they have stated in the primary objective [ Time Frame: at data analysis ]

Estimated Enrollment: 140
Study Start Date: December 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Using the information distributed with over−the−counter medication (The Patient Information Leaflet or PIL)
2
Paediatric Analgesia Slide (the new device)

Detailed Description:

Prescribing and administering drugs to children is difficult for both healthcare professionals and parents. The process is often performed poorly with under−dosing and over−dosing a major problem with sometimes fatal consequences.

The British National Formulary for Children (BNFC), introduced in 2005, has given hospital and community prescribers with a valuable reference text.

However, the comprehensive prescribing information presented in the BNFC and in the drug Summary of Product Characteristics is simplified in the Patient Information Leaflet (PIL) for interpretation by parents. When the PIL is analysed, it becomes apparent that the age−range regimens presented may result in under and over−dosing with large differences in the daily dose received by children depending on their age and weight.

The Paediatric Analgesia Slide is a simple device presenting pre−calculated volume (and therefore dose) information for parents. It allows for age/weight specific doses to be given thus minimising the risk of under and over−dosing. It also addresses the deficiency of the prescribing information in the PIL related to over and under−weight children.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
parents administering analgesic medication to their children
Criteria

Inclusion Criteria:

  • Any parent accompanying their child who is aged between 1 and 13 years old who is attending a hospital in County Durham and Darlington Acute Hospitals NHS Trust

Exclusion Criteria:

  • Those who have professional knowledge of prescribing or dispensing medicine (e.g. as a doctor, nurse or pharmacist);
  • Those who already have been given advice on the correct dose of paracetamol for their child as part of the current hospital episode;
  • Those who's child is under 1 year or over 13 years old and;
  • Those who have participated in this research before.
  Contacts and Locations
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): NCT00765609


Contacts
Contact: Richard C Hixson, BM BS, FRCA 0044 1325 743327 Richard.Hixson@cddft.nhs.uk

Locations
United Kingdom
County Durham and Darlington Acute Hospitals NHS Trust Not yet recruiting
Darlington, England, United Kingdom, DL3 6HX
Contact: Richard C Hixson, BM BS FRCA    0044 1325 743327    Richard.Hixson@cddft.nhs.uk   
Sponsors and Collaborators
County Durham and Darlington NHS Foundation Trust
Investigators
Principal Investigator: Richard C Hixson, BM BS, FRCA County Durham and Darlington Acute Hospitals NHS Trust
  More Information

Responsible Party: Dr Richard Hixson, County Durham and Darlington NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00765609     History of Changes
Other Study ID Numbers: 08/H0904/93
First Submitted: October 2, 2008
First Posted: October 3, 2008
Last Update Posted: October 3, 2008
Last Verified: September 2008

Keywords provided by County Durham and Darlington NHS Foundation Trust:
Paediatric
Analgesic
Prescribing
Parents