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

Postoperative Pain Clinical Trial

— Nurse-APS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01325077
• Other study ID #: Si 603/2010
• Secondary ID: 545/2553(EC3)
• Status: Recruiting
• Phase: Phase 3
• First received: March 6, 2011
• Last updated: March 27, 2011
• Start date: March 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2011
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 103
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 31 Days to 15 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative
• Postoperative Pain
• Satisfaction

Intervention

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.

Locations

Country	Name	City	State
Thailand	Departnment of Anesthesiology,Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours	Yes