Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy

Overview

The purpose of the study is to quantify the use of pain medications given to children aged 3 – 12 years as well as their pain level through pain scores after they have undergone a tonsillectomy or adenotonsillectomy surgery at Doernbecher Children's Hospital (DCH). We would like to learn more about the pain medications given and the pain scores of children post-surgery for the first 5 days following discharge from the hospital.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2020

Detailed Description

You and your child will be enrolled into the study during your child's scheduled surgery at DCH. Your child's surgery, anesthesia plan, and recovery will not change because of your participation in this study. Following discharge from the hospital, the study team will give you two follow-up phone calls that will take approximately 15 minutes. During these phone calls, we will ask you about your child's pain, any nausea or vomiting that has occurred, your child's intake of liquid and food, your child's activity level, and the medications they have been given over the course of the 5 days post-operation. Along with talking over the phone, we will ask you to document this information. After the post-operation day 6 phone call, you and your child will not be asked any additional questions for research purposes and we will ask you to return any documents you were given by the study team. Within 30 days of your and your child's participation in the study, the research team will pull medical information from your child's electronic medical record. Your child's electronic medical record will be reviewed to obtain demographic information such as date of birth, age, weight, ethnicity, medical history, and status information will also be collected such as allergies, potential complications, any pain scores collected during your child's post-anesthesia care unit (PACU) stay, and medical visits. 30 days after your child's surgery, you and your child will no longer be enrolled in this research study.

Interventions

  • Behavioral: Medication Tracking Form
    • Parents will complete medication tracking form for 5 days after child’s surgery. They will track medications administered, pain scores, nausea and vomiting

Arms, Groups and Cohorts

  • Pediatric tonsillectomy patients
    • All patients enrolled into study prior to undergoing tonsillectomy or adenotonsillectomy

Clinical Trial Outcome Measures

Primary Measures

  • Total opioid administered during POD 1-5 (converted to morphine dose equivalents)
    • Time Frame: POD 1-5
    • Total amount of opioid analgesics administered at home on Post-operative days 1-5.

Secondary Measures

  • Mean Worst Pain Scores POD 1-5
    • Time Frame: POD 1-5
    • Average of worst pain scores as documented twice a day on POD 1-5
  • Total acetaminophen administered on POD 1-5
    • Time Frame: POD 1-5
    • Total acetaminophen given (total dose and total quantity as mg/kg)
  • Total ibuprofen administered on POD 1-5
    • Time Frame: POD 1-5
    • Total ibuprofen given (total dose and total quantity as mg/kg)
  • Frequency of Vomiting on POD 1-5
    • Time Frame: POD 1-5
    • Number of days vomiting on POD 1-5
  • Duration of impaired drinking
    • Time Frame: POD 1-5
    • Return to normal drinking on POD 1-5
  • Duration of impaired eating
    • Time Frame: POD 1-5
    • Return to normal eating on POD 1-5
  • Duration of impaired activity
    • Time Frame: POD 1-5
    • Return to normal activity on POD 1-5

Participating in This Clinical Trial

Inclusion Criteria

  • Child aged 3-12 that is scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes or Parent or guardian of a child aged 3-12 years old that is scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes

Exclusion Criteria

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christine Martin, Principal Investigator – Oregon Health and Science University

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