PainNCT00765609
To Evaluate the Paediatric Analgesia Slide
An observational study of Pain, run by County Durham and Darlington NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: parents administering analgesic medication to their children
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
County Durham and Darlington Acute Hospitals NHS Trust
Darlington, England, DL3 6HX
Richard C Hixson, BM BS FRCA, 0044 1325 743327, Richard.Hixson@cddft.nhs.uk
About this study
Official title: To Evaluate the Paediatric Analgesia Slide, a New Device Developed to Assist Parents in Administering Paracetamol to Children at Home
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.
Read the 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.
- Conditions
- Pain
- Keywords
- Paediatric, Analgesic, Prescribing, Parents
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Using the information distributed with over-the-counter medication (The Patient Information Leaflet or PIL) | |
| 2 | Paediatric Analgesia Slide (the new device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device
Measured: at data analysis
Secondary outcomes (2)
Ability of parents to interpret the prescribing information related to minimum dosage interval and maximum dosage frequency
Measured: at data analysis
To assess whether parents can accurately draw up the volume that they have stated in the primary objective
Measured: at data analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2009 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- County Durham and Darlington NHS Foundation Trust
- Sponsor type
- Other government
- Investigators
- Richard C Hixson, BM BS, FRCA, Principal investigator, County Durham and Darlington Acute Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765609
- Sponsor's protocol ID
- 08/H0904/93
- Status last verified
- Sep 2008
- First submitted
- 2 Oct 2008
- Last updated
- 3 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Paediatric Analgesia Slide, a New Device Developed to Assist Parents in Administering Paracetamol to Children at Home
- ClinicalTrials.gov ID
- NCT00765609
- Acronym / sponsor ID
- 08/H0904/93
- Conditions
- Pain
- Keywords
- Paediatric, Analgesic, Prescribing, Parents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- County Durham and Darlington NHS Foundation TrustOther government
- Study start
- Dec 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Using the information distributed with over-the-counter medication (The Patient Information Leaflet or PIL) |
| 2 | – | –Paediatric Analgesia Slide (the new device) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- parents administering analgesic medication to their children
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device
Time frame: at data analysis
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard C Hixson, BM BS, FRCA principal investigator
County Durham and Darlington Acute Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by County Durham and Darlington NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard C Hixson, BM BS, FRCA (0044 1325 743327, Richard.Hixson@cddft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device (time frame: at data analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2008.