Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy

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 Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Obstructive Sleep Apnea of Child
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University (OHSU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Parent or guardian refusal of consent
2. Child has severe OSA (Apnea-Hypopnea Index (AHI) ≥10 or O2 Saturation <85% on polysomnogram)
3. Child with behavioral disorders (ADHD, ASD, etc.)
4. Child with genetic disorders (down syndrome, mucopolysaccharidoses, achondroplasia, Prader-Willi syndrome, etc.)
5. Child with neuromuscular disorders (muscular dystrophy, hypotonia, etc.)
6. Child with a history of extremely preterm (born at <28 weeks) or very preterm (born at 28-32 weeks)
7. Child with moderate to severe developmental delay
8. Child is obese (BMI ≥ 95th percentile)
9. Child with craniofacial anomalies (retrognathia, micrognathia, midface hypoplasia)
10. Child with allergies to acetaminophen, ibuprofen, morphine, fentanyl or oxycodone

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: tonsillectomy; adenotonsillectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Pain, Postoperative
• Other Study ID Numbers: 19199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No