Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy

Sponsor
Oregon Health and Science University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04349397
Collaborator
(none)
100
1
22
4.5

Study Details

Study Description

Brief Summary

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.
Condition or Disease Intervention/Treatment Phase
  • Behavioral: Medication Tracking Form

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy
Actual Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Pediatric tonsillectomy patients

All patients enrolled into study prior to undergoing tonsillectomy or adenotonsillectomy

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

Outcome Measures

Primary Outcome Measures

  1. Total opioid administered during POD 1-5 (converted to morphine dose equivalents) [POD 1-5]

    Total amount of opioid analgesics administered at home on Post-operative days 1-5.

Secondary Outcome Measures

  1. Mean Worst Pain Scores POD 1-5 [POD 1-5]

    Average of worst pain scores as documented twice a day on POD 1-5

  2. Total acetaminophen administered on POD 1-5 [POD 1-5]

    Total acetaminophen given (total dose and total quantity as mg/kg)

  3. Total ibuprofen administered on POD 1-5 [POD 1-5]

    Total ibuprofen given (total dose and total quantity as mg/kg)

  4. Frequency of Vomiting on POD 1-5 [POD 1-5]

    Number of days vomiting on POD 1-5

  5. Duration of impaired drinking [POD 1-5]

    Return to normal drinking on POD 1-5

  6. Duration of impaired eating [POD 1-5]

    Return to normal eating on POD 1-5

  7. Duration of impaired activity [POD 1-5]

    Return to normal activity on POD 1-5

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon Health & Science University (OHSU) Portland Oregon United States 97239

Sponsors and Collaborators

  • Oregon Health and Science University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christine Martin, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT04349397
Other Study ID Numbers:
  • 19199
First Posted:
Apr 16, 2020
Last Update Posted:
Apr 16, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christine Martin, Principal Investigator, Oregon Health and Science University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 16, 2020