Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy

Pain, Postoperative Clinical Trial

Official title:

Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04349397
• Other study ID #: 19199
• Status: Active, not recruiting
• Start date: August 1, 2019
• Est. completion date: June 2021

Study information

• Verified date: April 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Child
• Pain, Postoperative
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University (OHSU)	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid administered during POD 1-5 (converted to morphine dose equivalents)	Total amount of opioid analgesics administered at home on Post-operative days 1-5.	POD 1-5
Secondary	Mean Worst Pain Scores POD 1-5	Average of worst pain scores as documented twice a day on POD 1-5	POD 1-5
Secondary	Total acetaminophen administered on POD 1-5	Total acetaminophen given (total dose and total quantity as mg/kg)	POD 1-5
Secondary	Total ibuprofen administered on POD 1-5	Total ibuprofen given (total dose and total quantity as mg/kg)	POD 1-5
Secondary	Frequency of Vomiting on POD 1-5	Number of days vomiting on POD 1-5	POD 1-5
Secondary	Duration of impaired drinking	Return to normal drinking on POD 1-5	POD 1-5
Secondary	Duration of impaired eating	Return to normal eating on POD 1-5	POD 1-5
Secondary	Duration of impaired activity	Return to normal activity on POD 1-5	POD 1-5