NCT00765609

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 3, 2008

Status Verified

September 1, 2008

Enrollment Period

2 months

First QC Date

October 2, 2008

Last Update Submit

October 2, 2008

Conditions

Keywords

PaediatricAnalgesicPrescribingParents

Outcome Measures

Primary Outcomes (1)

  • Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device

    at data analysis

Secondary Outcomes (2)

  • Ability of parents to interpret the prescribing information related to minimum dosage interval and maximum dosage frequency

    at data analysis

  • To assess whether parents can accurately draw up the volume that they have stated in the primary objective

    at data analysis

Study Arms (2)

1

Using the information distributed with over-the-counter medication (The Patient Information Leaflet or PIL)

2

Paediatric Analgesia Slide (the new device)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

parents administering analgesic medication to their children

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

County Durham and Darlington Acute Hospitals NHS Trust

Darlington, England, DL3 6HX, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard C Hixson, BM BS, FRCA

    County Durham and Darlington Acute Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard C Hixson, BM BS, FRCA

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 3, 2008

Study Start

December 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

October 3, 2008

Record last verified: 2008-09

Locations