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Efficacy of a Nurse-based, Anesthesiologist-supervised Acute Pain Service for Pediatric Patients (Nurse-APS)

Primary Purpose

Postoperative Pain, Satisfaction

Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
model of health care service
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Nurse-based, acute pain service, pediatric, postoperative,, pain

Eligibility Criteria

31 Days - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age up to15 years old
  • Underwent surgery with moderate to severe pain

Exclusion Criteria:

  • ENT, Eye, ambulatory surgery
  • Cardiac, Neurosurgery
  • Severe neurocognitive impairment
  • Continuous epidural analgesia which anesthesiologists take care by themselves

Sites / Locations

  • Departnment of Anesthesiology,Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conventional model, Study model

Arm Description

Conventional model(C): Nurses give fixed-dose analgesic according to surgeons' prescription Study model(S): Nurses give initial-dose analgesic according to surgeons' prescription. In case of inadequate pain relief, another half of initial dose will be given twice at 15-min interval and acute pain service will be consulted if there is still pain.

Outcomes

Primary Outcome Measures

prevalence of patients with moderate to severe pain more than once in first postoperative day
moderate to severe pain = Neonatal Infant Pain Scale =,>4 or CHEOPS =,>8 or Verbal numerating scale =,>4

Secondary Outcome Measures

Full Information

First Posted
March 6, 2011
Last Updated
March 27, 2011
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01325077
Brief Title
Efficacy of a Nurse-based, Anesthesiologist-supervised Acute Pain Service for Pediatric Patients
Acronym
Nurse-APS
Official Title
Efficacy of a Nurse-based, Anesthesiologist-supervised Acute Pain Service for Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Can a nurse-based, anesthesiologist-supervised model reduce prevalence of postoperative pain in pediatric patients?
Detailed Description
Comparison of 2 treatment model in reducing prevalence of postoperative pain in pediatric patients: Conventional model(C): Nurses give fixed-dose analgesic according to surgeons' prescription Study model(S): Nurses give initial-dose analgesic according to surgeons' prescription. In case of inadequate pain relief, another half of initial dose will be given twice at 15-min interval and acute pain service will be consulted if there is still pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Satisfaction
Keywords
Nurse-based, acute pain service, pediatric, postoperative,, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
103 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional model, Study model
Arm Type
Experimental
Arm Description
Conventional model(C): Nurses give fixed-dose analgesic according to surgeons' prescription Study model(S): Nurses give initial-dose analgesic according to surgeons' prescription. In case of inadequate pain relief, another half of initial dose will be given twice at 15-min interval and acute pain service will be consulted if there is still pain.
Intervention Type
Other
Intervention Name(s)
model of health care service
Intervention Description
Conventional model(C): Nurses give fixed-dose analgesic according to surgeons' prescription Study model(S): Nurses give initial-dose analgesic according to surgeons' prescription. In case of inadequate pain relief, another half of initial dose will be given twice at 15-min interval and acute pain service will be consulted if there is still pain.
Primary Outcome Measure Information:
Title
prevalence of patients with moderate to severe pain more than once in first postoperative day
Description
moderate to severe pain = Neonatal Infant Pain Scale =,>4 or CHEOPS =,>8 or Verbal numerating scale =,>4
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Days
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age up to15 years old Underwent surgery with moderate to severe pain Exclusion Criteria: ENT, Eye, ambulatory surgery Cardiac, Neurosurgery Severe neurocognitive impairment Continuous epidural analgesia which anesthesiologists take care by themselves
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suwannee Suraseranivongse, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departnment of Anesthesiology,Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suwannee Suraseraniwongse, MD
Phone
6624113256
Email
sisur@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Suwannee Suraseranivongse, MD

12. IPD Sharing Statement

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Efficacy of a Nurse-based, Anesthesiologist-supervised Acute Pain Service for Pediatric Patients

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