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Evaluation of Post-PACU Pain Management in Pediatric Surgery

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ClinicalTrials.gov Identifier: NCT02352116
Recruitment Status : Recruiting
First Posted : February 2, 2015
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Lena S. Sun, Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Other: Additional face-to-face education Other: Standard of care management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of Post-PACU Pain Management Experiences in Pediatric Ambulatory Surgery Patients
Study Start Date : June 2013
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Additional education
Subjects undergoing ambulatory surgery who receive standard of care management with additional face-to-face education in postoperative pain management.
Other: Additional face-to-face education
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

Other: Standard of care management
Current standard of care at a major U.S. teaching hospital.

Active Comparator: No additional education
Subjects undergoing ambulatory surgery who receive standard of care management with no additional education in postoperative pain management.
Other: Standard of care management
Current standard of care at a major U.S. teaching hospital.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Postoperative Anesthesia Emergence Delirium (PAED) Score [ Time Frame: baseline, 72 hours, 7-14 days, up to 4 weeks ]
    Validated 5-question survey completed by nurses after arrival in the post-operative anesthesia unit

  2. Change in Emotionality, Activity, Sociability, Impulsivity Instrument of child Temperament (EASI) Scale [ Time Frame: baseline, 72 hours, 7-14 days, up to 4 weeks ]

    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.


  3. Change in Modified Yale Preoperative Anxiety Scale (mYPAS) [ Time Frame: baseline, 72 hours, 7-14 days, up to 4 weeks ]
    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

  4. Change in Post-Hospital Behavior Questionnaire Score [ Time Frame: baseline, 72 hours, 7-14 days, up to 4 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352116


Contacts
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Contact: Lena Sun, MD 212-305-2413

Locations
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United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Lena Sun, MD    212-305-2413      
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Lena Sun, MD Columbia University
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Responsible Party: Lena S. Sun, Emanuel M. Papper Professor of Anesthesiology and Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT02352116    
Other Study ID Numbers: AAAI5954
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Keywords provided by Lena S. Sun, Columbia University:
Postoperative Experience
Postoperative Behavioral Changes
Maladaptive Behavioral Changes