Study of the Impact of a Pain Diary in Pediatric Patients | NCT00935207

Studies
Study of the Impact of a Pain Diary in Pediatric Patients

NCT00935207

Sponsor

University of Mississippi Medical Center

Status

Terminated

Last Update Posted

May 3, 2013Estimated

Enrollment

8Actual

Phase

Not provided

Conditions

Pain

Interventions

Pediatric Pain Diary

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor enrollment and data collection

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 17, 2009

First Submission Date that Met QC Criteria

Jul 7, 2009

First Posted Date

Jul 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2013

Last Update Posted Date

May 3, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrew Ostrenga, Pharmacist, University of Mississippi Medical CenterPrincipal Investigator

Lead Sponsor

University of Mississippi Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric Pain Diary		Patients will be give a pain diary to complete.	Other: Pediatric Pain Diary

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pediatric Pain Diary	Other	Pain diary designed for pediatric patients	Pediatric Pain Diary

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Child Survey		Hospital discharge
Parent Survey		Hospital Discharge
Nurse Survey		Hospital Discharge
Physician Survey		Hospital Discharge

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Ostrenga, Pharm.D.	University of Mississippi Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Mississippi Medical Center		Jackson	Mississippi	39216	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided