Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy

NCT ID: NCT04349397

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-06-30

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.

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.

Conditions

Pain, Postoperative; Obstructive Sleep Apnea of Child

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric tonsillectomy patients

All patients enrolled into study prior to undergoing tonsillectomy or adenotonsillectomy

Medication Tracking Form

Intervention Type: BEHAVIORAL

Parents will complete medication tracking form for 5 days after child's surgery. They will track medications administered, pain scores, nausea and vomiting

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

-

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Christine Martin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Countries

United States

Other Identifiers

19199

Identifier Type: -

Identifier Source: org_study_id