Postoperative PainPhase 3Nurse-APSNCT01325077
Efficacy of a Nurse-based, Anesthesiologist-supervised Acute Pain Service for Pediatric Patients
A Phase 3 study testing model of health care service in people with Postoperative Pain and Satisfaction, run by Mahidol University at 1 site in Thailand.
Trial summary
Can a nurse-based, anesthesiologist-supervised model reduce prevalence of postoperative pain in pediatric patients? Read more about this study
- Who is it for?
- Ages 31 days to 15 years
- Conditions the study is for
- Postoperative Pain, Satisfaction
- What is being tested?
- model of health care service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2011to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 days to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age up to15 years old
- Underwent surgery with moderate to severe pain
Who cannot join
- ENT, Eye, ambulatory surgery
- Cardiac, Neurosurgery
- Severe neurocognitive impairment
- Continuous epidural analgesia which anesthesiologists take care by themselves
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Departnment of Anesthesiology,Siriraj Hospital, Mahidol University
Bangkok, 10700
Suwannee Suraseraniwongse, MD, 6624113256, sisur@mahidol.ac.th
Suwannee Suraseranivongse, MD
About this study
Can a nurse-based, anesthesiologist-supervised model reduce prevalence of postoperative pain in pediatric patients?
Read the 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.
- Conditions
- Postoperative Pain, Satisfaction
- Being tested
- model of health care service
- Keywords
- Nurse-based, acute pain service, pediatric, postoperative,, pain
- Medical subject headings
- Pain, Postoperative, Personal Satisfaction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: model of health care service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Suwannee Suraseranivongse, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325077
- Sponsor's protocol ID
- Si 603/2010
- Other IDs
- 545/2553(EC3)
- Acronym
- Nurse-APS
- Status last verified
- Mar 2011
- First submitted
- 6 Mar 2011
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Nurse-based, Anesthesiologist-supervised Acute Pain Service for Pediatric Patients
- ClinicalTrials.gov ID
- NCT01325077
- Acronym / sponsor ID
- Nurse-APS / Si 603/2010
- Conditions
- Postoperative Pain, Satisfaction
- Keywords
- Nurse-based, acute pain service, pediatric, postoperative,, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional model, Study model | Experimental | Other: model of health care serviceConventional 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. |
Who may qualify
- Ages
- 31 days to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age up to15 years old
- Underwent surgery with moderate to severe pain
Key exclusion criteria (4 listed)
- ENT, Eye, ambulatory surgery
- Cardiac, Neurosurgery
- Severe neurocognitive impairment
- Continuous epidural analgesia which anesthesiologists take care by themselves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| model of health care serviceConventional 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 | Conventional model, Study model |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Departnment of Anesthesiology,Siriraj Hospital, Mahidol University
Bangkok, Thailand
Suwannee Suraseranivongse, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing model of health care service in people with Postoperative Pain and Satisfaction, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of patients with moderate to severe pain more than once in first postoperative day (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011.