Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

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Recruitment Status : Withdrawn (Lost research support for enrolling patients)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

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

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

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

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

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

Original Estimated Enrollment ^ICMJE

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

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:

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

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