- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00935207
Study of the Impact of a Pain Diary in Pediatric Patients
May 2, 2013 updated by: Andrew Ostrenga, University of Mississippi Medical Center
The Impact of a Pain Diary on the Communication of Pain in Pediatric Patients
The purpose of this study is to show the impact of a pain diary on the communication of pain by pediatric patients.
Participants will be given a pain diary after consent and asked to complete the record each time they have pain.
A survey about the efficacy of the pain diary will be taken prior to discharge by the nurse, physician, patient and parents.
The hypothesis is that the pain diary will improve the communication.
Study Overview
Study Type
Observational
Enrollment (Actual)
8
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen.
Description
Inclusion Criteria:
- Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen.
Exclusion Criteria:
- Admitted to the Pediatric Intensive Care Unit
- Surgical patients, defined as patients having surgery since admission other than minor procedures
- Patients anticipated to receive pain medication for less than 24 hours
- Patients unable to verbally communicate their pain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric Pain Diary
Patients will be give a pain diary to complete.
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Pain diary designed for pediatric patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Child Survey
Time Frame: Hospital discharge
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Hospital discharge
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Parent Survey
Time Frame: Hospital Discharge
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Hospital Discharge
|
Nurse Survey
Time Frame: Hospital Discharge
|
Hospital Discharge
|
Physician Survey
Time Frame: Hospital Discharge
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Hospital Discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew Ostrenga, Pharm.D., University of Mississippi Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
June 17, 2009
First Submitted That Met QC Criteria
July 7, 2009
First Posted (Estimate)
July 8, 2009
Study Record Updates
Last Update Posted (Estimate)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 2, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 2009-0054
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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