PainNCT02352116
Evaluation of Post-PACU Pain Management in Pediatric Surgery
A study testing Additional face-to-face education in people with Pain, run by Columbia University at 1 site in United States.
Trial summary
This study aims to assess the differences in overall pain severity, pain management, and satisfaction during recovery period between two groups of children who either receive or do not receive additional education related to expectation and management of postoperative pain. Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Additional face-to-face education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients ages 1-6 years undergoing ambulatory surgical procedures.
- Patients with an ASA status of I or II spending 23 hours or less recovering in the PACU and discharged home.
Who cannot join
- Patients with an ASA status of III or IV.
- Patients admitted as inpatients or transferred to the PICU or inpatient for recovery, and any conditions that may affect pain expression or sensation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lena S. Sun, MD contact
United States1 site, 1 recruiting
- Recruiting
Columbia University
New York, New York, 10032
Lena Sun, MD, 212-305-2413
About this study
Official title: Evaluation of Post-PACU Pain Management Experiences in Pediatric Ambulatory Surgery Patients
This study aims to assess the differences in overall pain severity, pain management, and satisfaction during recovery period between two groups of children who either receive or do not receive additional education related to expectation and management of postoperative pain.
Read the detailed description
With the increased frequency and popularity of pediatric ambulatory surgery, there is a greater need for evaluation of the postoperative pain experience after discharge from the hospital. Pain is one of the most significant factors affecting the postoperative experience in adults, and also be true in the pediatric population. Control of postoperative pain in children after discharge from the hospital poses particular challenges due to dependence on parental or caretaker ability to properly evaluate the child's pain, their understanding of appropriate dosing of pain medications, and their willingness to administer enough medications until sufficient relief is achieved.
The investigators aim to assess the differences in reported pain between groups who receive additional face-to-face education versus the current standard of care at a major US teaching hospital. The study will assess pain management after surgery using parental reports and questionnaires to assess their child's pain at multiple time points during the study. Additionally, this study will also assess baseline behavioral attributes of children and will compare behavioral changes at 24-48 hours, 7-10 days, and 2-4 weeks postoperatively as these behavior changes may also affect overall postoperative experience.
This study is divided into phase I and phase II. Phase I is the initial assessment of the investigators' institution's pain management in healthy pediatric patients undergoing ambulatory surgical procedures. Phase II consists of randomized trial which includes a randomized intervention group and control group. The group selected randomly for intervention will receive additional teaching regarding what to expect in terms of postoperative pain and how to properly identify pain in children.
- Conditions
- Pain
- Being tested
- Additional face-to-face education, Standard of care management
- Keywords
- Postoperative Experience, Postoperative Behavioral Changes, Maladaptive Behavioral Changes
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional face-to-face educationOther
Additional teaching regarding what to expect in terms of postoperative pain, how to properly identify pain in children, and instruction on the proper administration of analgesic medications
Standard of care managementOther
Current standard of care at a major U.S. teaching hospital.
| Study group | Role | What they receive |
|---|---|---|
| Additional education | Experimental | Subjects undergoing ambulatory surgery who receive standard of care management with additional face-to-face education in postoperative pain management. Receives: Other: Additional face-to-face education; Other: Standard of care management |
| No additional education | Active comparator | Subjects undergoing ambulatory surgery who receive standard of care management with no additional education in postoperative pain management. Receives: Other: Standard of care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postoperative Pain Measure for Parents Score
Validated questionnaire for parental assessment of pain in children ages 1-12 years
Measured: baseline, 72 hours, 7-14 days, up to 4 weeks
Secondary outcomes (4)
Change in Postoperative Anesthesia Emergence Delirium (PAED) Score
Validated 5-question survey completed by nurses after arrival in the post-operative anesthesia unit
Measured: baseline, 72 hours, 7-14 days, up to 4 weeks
Change in Emotionality, Activity, Sociability, Impulsivity Instrument of child Temperament (EASI) Scale
The EASI is a parent report form that assesses a child's baseline temperament and yields subscales including emotionality and activity level.
The scale contains 14 items to which participants respond on a 5- point Likert scale ranging from "Strongly disagree" to "Strongly agree". Higher scores indicate greater emotionality.
Measured: baseline, 72 hours, 7-14 days, up to 4 weeks
Change in Modified Yale Preoperative Anxiety Scale (mYPAS)
An observational measure of children's preoperative anxiety. Contains 27 items that measure activity, emotional expressivity, state of arousal, vocalization, use of parents. This must be administered by trained research assistants. Validated for children ages 2 and older
Measured: baseline, 72 hours, 7-14 days, up to 4 weeks
Change in Post-Hospital Behavior Questionnaire Score
A validated questionnaire to be completed by the parents. This measure contains 27 items that evaluate a child's general anxiety, separation anxiety, anxiety about sleep, easting disturbance, aggression toward authority, and apathy/withdrawal
Measured: baseline, 72 hours, 7-14 days, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJun 2013
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Columbia 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena S. Sun, Columbia University
- Investigators
- Lena S. Sun, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352116
- Sponsor's protocol ID
- AAAI5954
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2014
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-PACU Pain Management Experiences in Pediatric Ambulatory Surgery Patients
- ClinicalTrials.gov ID
- NCT02352116
- Acronym / sponsor ID
- AAAI5954
- Conditions
- Pain
- Keywords
- Postoperative Experience, Postoperative Behavioral Changes, Maladaptive Behavioral Changes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Feb 2015 (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.
This study aims to assess the differences in overall pain severity, pain management, and satisfaction during recovery period between two groups of children who either receive or do not receive additional education related to expectation and management of postoperative pain.
Detailed description
With the increased frequency and popularity of pediatric ambulatory surgery, there is a greater need for evaluation of the postoperative pain experience after discharge from the hospital. Pain is one of the most significant factors affecting the postoperative experience in adults, and also be true in the pediatric population. Control of postoperative pain in children after discharge from the hospital poses particular challenges due to dependence on parental or caretaker ability to properly evaluate the child's pain, their understanding of appropriate dosing of pain medications, and their willingness to administer enough medications until sufficient relief is achieved.
The investigators aim to assess the differences in reported pain between groups who receive additional face-to-face education versus the current standard of care at a major US teaching hospital. The study will assess pain management after surgery using parental reports and questionnaires to assess their child's pain at multiple time points during the study. Additionally, this study will also assess baseline behavioral attributes of children and will compare behavioral changes at 24-48 hours, 7-10 days, and 2-4 weeks postoperatively as these behavior changes may also affect overall postoperative experience.
This study is divided into phase I and phase II. Phase I is the initial assessment of the investigators' institution's pain management in healthy pediatric patients undergoing ambulatory surgical procedures. Phase II consists of randomized trial which includes a randomized intervention group and control group. The group selected randomly for intervention will receive additional teaching regarding what to expect in terms of postoperative pain and how to properly identify pain in children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional education | Experimental | Other: Additional face-to-face education, Other: Standard of care managementSubjects undergoing ambulatory surgery who receive standard of care management with additional face-to-face education in postoperative pain management. |
| No additional education | Active comparator | Other: Standard of care managementSubjects undergoing ambulatory surgery who receive standard of care management with no additional education in postoperative pain management. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients ages 1-6 years undergoing ambulatory surgical procedures.
- Patients with an ASA status of I or II spending 23 hours or less recovering in the PACU and discharged home.
Key exclusion criteria (2 listed)
- Patients with an ASA status of III or IV.
- Patients admitted as inpatients or transferred to the PICU or inpatient for recovery, and any conditions that may affect pain expression or sensation.
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 |
|---|---|---|
| Additional face-to-face educationAdditional teaching regarding what to expect in terms of postoperative pain, how to properly identify pain in children, and instruction on the proper administration of analgesic medications | Other | Additional education |
| Standard of care managementCurrent standard of care at a major U.S. teaching hospital. | Other | Additional education, No additional education |
Primary outcome
Change in Postoperative Pain Measure for Parents Score
Time frame: baseline, 72 hours, 7-14 days, up to 4 weeks
Validated questionnaire for parental assessment of pain in children ages 1-12 years
4 secondary outcomes
Change in Postoperative Anesthesia Emergence Delirium (PAED) Score
Time frame: baseline, 72 hours, 7-14 days, up to 4 weeks
Change in Emotionality, Activity, Sociability, Impulsivity Instrument of child Temperament (EASI) Scale
Time frame: baseline, 72 hours, 7-14 days, up to 4 weeks
Change in Modified Yale Preoperative Anxiety Scale (mYPAS)
Time frame: baseline, 72 hours, 7-14 days, up to 4 weeks
Change in Post-Hospital Behavior Questionnaire Score
Time frame: baseline, 72 hours, 7-14 days, up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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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.
Lena S. Sun, MD contact
Lena S. Sun, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional face-to-face education in people with Pain, run by Columbia University at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lena S. Sun, MD (212-305-2413), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postoperative Pain Measure for Parents Score (time frame: baseline, 72 hours, 7-14 days, up to 4 weeks). 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 23 Apr 2026.