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Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528343
Recruitment Status : Withdrawn (Lost research support for enrolling patients)
First Posted : May 17, 2018
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
Primary Children's Hospital
Information provided by (Responsible Party):
Sean Stokes, University of Utah

Brief Summary:

There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design.

Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up.

The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.


Condition or disease Intervention/treatment Phase
Appendicitis Pain, Postoperative Drug: Non-narcotic pain control Phase 1 Phase 2

Detailed Description:

There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design.

Children admitted after undergoing surgical management for a diagnosis of acute appendicitis will be randomized at discharge to a narcotic arm or a tylenol/motrin arm. The narcotic arm will receive the standard of care narcotic prescription. The tylenol/motrin arm will receive education to use tylenol and motrin for pain control as well as a paper prescription provided for the sole purpose of rescue.

Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up.

The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy: A Randomized Controlled Trial
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tylenol/Motrin
Group of patients who will receive instructions to use tylenol and motrin for pain control, and parents will be sent home with a paper prescription with a rescue does of standard of care narcotics. They will be instructed to only use the rescue dose if pain is uncontrolled using over the counter medications.
Drug: Non-narcotic pain control
Education to use tylenol and motrin only for pain control unless this is unable to control pain. Rescue prescription provided.

No Intervention: Narcotic
Group of patients who will receive the standard of care narcotic prescription filled upon discharge.



Primary Outcome Measures :
  1. Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM) [ Time Frame: 2-week follow-up visit ]
    Parental satisfaction with pain control at home following pediatric appendectomy as assessed by the validated Parental Post-operative Pain Measure (PPPM)


Secondary Outcome Measures :
  1. Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM) [ Time Frame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up ]
    Parental satisfaction with pain control at home following pediatric appendectomy as assessed by Parental Post-operative Pain Measure (PPPM)

  2. Patient pain control satisfaction using adaptation of Parental Post-operative Pain Measure (PPPM) [ Time Frame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up ]
    Patient satisfaction with pain control at home following pediatric appendectomy as assessed by an adaptation of Parental Post-operative Pain Measure (PPPM)

  3. Patient pain scores using Wong-Baker Faces Pain Rating Scale [ Time Frame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up ]
    Patient description of pain control using validated Wong-Baker Faces Pain Rating Scale. This scale presents the subject with a series of 6 depictions of faces and a text description of pain level. The range is from 0 "No Hurt" to 10 "Hurts Worst".

  4. Number of pain medications used [ Time Frame: Post-operative days 1-14 (until follow-up) ]
    Number of pain medications used

  5. Days of pain medication requirement after discharge [ Time Frame: Post-operative days 1-14 (until follow-up) ]
    Number of days patient required pain medication

  6. Number of pain medication side effects [ Time Frame: Post-operative days 1-14 (until follow-up) ]
    Side effects experienced by taking pain medications following surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 0 to 18 years old
  • Patients have undergone appendectomy by any technique (open, laparoscopic, single-port)

Exclusion Criteria:

  • Patients on chronic opioids
  • Patient undergoes a more extensive or additional procedures at the time of operation due to complications or other indication
  • Pregnancy

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): NCT03528343


Locations
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United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
University of Utah
Primary Children's Hospital
Investigators
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Principal Investigator: Stephen J Fenton, MD University of Utah, Primary Children's Hospital
Publications:

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Responsible Party: Sean Stokes, General Surgery Resident, University of Utah
ClinicalTrials.gov Identifier: NCT03528343    
Other Study ID Numbers: UU83426
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sean Stokes, University of Utah:
appendicitis
postoperative pain
patient satisfaction
children
pediatric
narcotic
pain control
Additional relevant MeSH terms:
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Appendicitis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases