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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01325077
First received: March 6, 2011
Last updated: March 27, 2011
Last verified: March 2011
History of Changes
  Purpose

Can a nurse-based, anesthesiologist-supervised model reduce prevalence of postoperative pain in pediatric patients?


Condition Intervention Phase
Postoperative Pain
Satisfaction
 Other: model of health care service
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of a Nurse-based, Anesthesiologist-supervised Acute Pain Service for Pediatric Patients

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • prevalence of patients with moderate to severe pain more than once in first postoperative day [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    moderate to severe pain = Neonatal Infant Pain Scale =,>4 or CHEOPS =,>8 or Verbal numerating scale =,>4


Estimated Enrollment: 103
Study Start Date: March 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   31 Days to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325077

Locations
Thailand
Departnment of Anesthesiology,Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Suwannee Suraseraniwongse, MD     6624113256     sisur@mahidol.ac.th    
Principal Investigator: Suwannee Suraseranivongse, MD            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Suwannee Suraseranivongse, MD Mahidol University
  More Information

No publications provided

Responsible Party: Professor Suwannee Suraseranivongse, Faculty of Medicine Siriraj hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT01325077     History of Changes
Other Study ID Numbers: Si 603/2010, 545/2553(EC3)
Study First Received: March 6, 2011
Last Updated: March 27, 2011
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Mahidol University:
Nurse-based, acute pain service, pediatric, postoperative,
pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013