Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparing Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy: A Randomized Controlled Trial

Conditions
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Appendicitis, Pain, Postoperative

Intervention / Treatment
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* Drug: Non-narcotic pain control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tylenol/Motrin<br>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<br>* Education to use tylenol and motrin only for pain control unless this is unable to control pain. Rescue prescription provided.<br>|
| No Intervention: Narcotic<br>Group of patients who will receive the standard of care narcotic prescription filled upon discharge. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2-week follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up | 
| 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) | Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up | 
| 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. | Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up | 
| Number of pain medications used | Number of pain medications used | Post-operative days 1-14 (until follow-up) | 
| Days of pain medication requirement after discharge | Number of days patient required pain medication | Post-operative days 1-14 (until follow-up) | 
| Number of pain medication side effects | Side effects experienced by taking pain medications following surgery | Post-operative days 1-14 (until follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appendicitis, postoperative pain, patient satisfaction, children, pediatric, narcotic, pain control