Clinical trial NCT04349397: Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy
Official title: Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Obstructive Sleep Apnea of Child
Keywords: tonsillectomy
adenotonsillectomy
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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:

-

Primary outcomes:
measure: Total opioid administered during POD 1-5 (converted to morphine dose equivalents)
timeFrame: POD 1-5
Secondary outcomes:
measure: Mean Worst Pain Scores POD 1-5
timeFrame: POD 1-5
measure: Total acetaminophen administered on POD 1-5
timeFrame: POD 1-5
measure: Total ibuprofen administered on POD 1-5
timeFrame: POD 1-5
measure: Frequency of Vomiting on POD 1-5
timeFrame: POD 1-5
measure: Duration of impaired drinking
timeFrame: POD 1-5
measure: Duration of impaired eating
timeFrame: POD 1-5
measure: Duration of impaired activity
timeFrame: POD 1-5
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
Study officials:
References: