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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Recruitment Status : Withdrawn (Lost research support for enrolling patients)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

Tracking Information
First Submitted Date  ICMJE September 12, 2017
First Posted Date  ICMJE May 17, 2018
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE September 5, 2017
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • 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)
  • Patient pain control satisfaction using adaptation of Parental Post-operative Pain Measure (PPPM) [ Time Frame: 2-week follow-up visit ]
    Patient satisfaction with pain control at home following pediatric appendectomy as assessed by an adaptation of Parental Post-operative Pain Measure (PPPM)
  • Patient pain score using Wong-Baker pain rating scale [ Time Frame: 2-week follow-up visit ]
    Patient description of pain control using validated Wong-Baker pain rating scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
  • 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)
  • 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)
  • 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".
  • Number of pain medications used [ Time Frame: Post-operative days 1-14 (until follow-up) ]
    Number of pain medications used
  • Days of pain medication requirement after discharge [ Time Frame: Post-operative days 1-14 (until follow-up) ]
    Number of days patient required pain medication
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • 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)
  • 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)
  • Patient pain scores using Wong-Baker 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 pain rating scale
  • Number of pain medications used [ Time Frame: Post-operative days 1-14 (until follow-up) ]
    Number of pain medications used
  • Days of pain medication requirement after discharge [ Time Frame: Post-operative days 1-14 (until follow-up) ]
    Number of days patient required pain medication
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
Official Title  ICMJE Comparing Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy: A Randomized Controlled Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Appendicitis
  • Pain, Postoperative
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Non-narcotic pain control
  • No Intervention: Narcotic
    Group of patients who will receive the standard of care narcotic prescription filled upon discharge.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 3, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2018)
400
Actual Study Completion Date  ICMJE December 1, 2017
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528343
Other Study ID Numbers  ICMJE UU83426
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sean Stokes, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Primary Children's Hospital
Investigators  ICMJE
Principal Investigator: Stephen J Fenton, MD University of Utah, Primary Children's Hospital
PRS Account University of Utah
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP