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Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

Primary Purpose

Appendicitis, Pain, Postoperative

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Non-narcotic pain control
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring appendicitis, postoperative pain, patient satisfaction, children, pediatric, narcotic, pain control

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Primary Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tylenol/Motrin

Narcotic

Arm Description

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.

Group of patients who will receive the standard of care narcotic prescription filled upon discharge.

Outcomes

Primary Outcome Measures

Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
Parental satisfaction with pain control at home following pediatric appendectomy as assessed by the validated Parental Post-operative Pain Measure (PPPM)

Secondary Outcome Measures

Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
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)
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
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
Number of pain medications used
Days of pain medication requirement after discharge
Number of days patient required pain medication
Number of pain medication side effects
Side effects experienced by taking pain medications following surgery

Full Information

First Posted
September 12, 2017
Last Updated
February 5, 2020
Sponsor
University of Utah
Collaborators
Primary Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03528343
Brief Title
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
Official Title
Comparing Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lost research support for enrolling patients
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Primary Children's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Pain, Postoperative
Keywords
appendicitis, postoperative pain, patient satisfaction, children, pediatric, narcotic, pain control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tylenol/Motrin
Arm Type
Experimental
Arm Description
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.
Arm Title
Narcotic
Arm Type
No Intervention
Arm Description
Group of patients who will receive the standard of care narcotic prescription filled upon discharge.
Intervention Type
Drug
Intervention Name(s)
Non-narcotic pain control
Intervention Description
Education to use tylenol and motrin only for pain control unless this is unable to control pain. Rescue prescription provided.
Primary Outcome Measure Information:
Title
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
Description
Parental satisfaction with pain control at home following pediatric appendectomy as assessed by the validated Parental Post-operative Pain Measure (PPPM)
Time Frame
2-week follow-up visit
Secondary Outcome Measure Information:
Title
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
Description
Parental satisfaction with pain control at home following pediatric appendectomy as assessed by Parental Post-operative Pain Measure (PPPM)
Time Frame
Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Title
Patient pain control satisfaction using adaptation of Parental Post-operative Pain Measure (PPPM)
Description
Patient satisfaction with pain control at home following pediatric appendectomy as assessed by an adaptation of Parental Post-operative Pain Measure (PPPM)
Time Frame
Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Title
Patient pain scores using Wong-Baker Faces Pain Rating Scale
Description
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".
Time Frame
Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Title
Number of pain medications used
Description
Number of pain medications used
Time Frame
Post-operative days 1-14 (until follow-up)
Title
Days of pain medication requirement after discharge
Description
Number of days patient required pain medication
Time Frame
Post-operative days 1-14 (until follow-up)
Title
Number of pain medication side effects
Description
Side effects experienced by taking pain medications following surgery
Time Frame
Post-operative days 1-14 (until follow-up)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Fenton, MD
Organizational Affiliation
University of Utah, Primary Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9840903
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
21958060
Citation
Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29.
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Citation
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Results Reference
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PubMed Identifier
8867249
Citation
Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.
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Abou-Karam M, Dube S, Kvann HS, Mollica C, Racine D, Bussieres JF, Lebel D, Nguyen C, Thibault M. Parental Report of Morphine Use at Home after Pediatric Surgery. J Pediatr. 2015 Sep;167(3):599-604.e1-2. doi: 10.1016/j.jpeds.2015.06.035. Epub 2015 Jul 21.
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Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

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