NCT01325077

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
103

participants targeted

Target at P25-P50 for phase_3 postoperative-pain

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

7 months

First QC Date

March 6, 2011

Last Update Submit

March 27, 2011

Conditions

Postoperative PainSatisfaction

Keywords

Nurse-based, acute pain service, pediatric, postoperative,pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Conventional model, Study model

EXPERIMENTAL

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

Interventions

model of health care serviceOTHER

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.

Conventional model, Study model

Eligibility Criteria

Age31 Days - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departnment of Anesthesiology,Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePersonal SatisfactionPain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsBehavior

Study Officials

  • Suwannee Suraseranivongse, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2011

First Posted

March 29, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations

TH(1)