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

March 27, 2011 updated by: Mahidol University
Can a nurse-based, anesthesiologist-supervised model reduce prevalence of postoperative pain in pediatric patients?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

103

Phase

  • Phase 3

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

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Departnment of Anesthesiology,Siriraj Hospital, Mahidol University
        • Principal Investigator:
          • Suwannee Suraseranivongse, MD
        • Contact:

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

1 month to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional model, Study model
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.
Other: model of health care service
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of patients with moderate to severe pain more than once in first postoperative day
Time Frame: 24 hours
moderate to severe pain = Neonatal Infant Pain Scale =,>4 or CHEOPS =,>8 or Verbal numerating scale =,>4
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Suwannee Suraseranivongse, MD, Mahidol University

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

March 1, 2011

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

March 6, 2011

First Submitted That Met QC Criteria

March 27, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Estimate)

March 29, 2011

Last Update Submitted That Met QC Criteria

March 27, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 603/2010
  • 545/2553(EC3) (Registry Identifier: 545/2553(EC3))

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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