Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy

NCT04349397 | Unknown DMC

• 1 other identifier: 19199
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Obstructive Sleep Apnea of Child

Keywords

tonsillectomy; adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean Worst Pain Scores POD 1-5

  POD 1-5

• Total acetaminophen administered on POD 1-5

  POD 1-5

• Total ibuprofen administered on POD 1-5

  POD 1-5

• Frequency of Vomiting on POD 1-5

  POD 1-5

• Duration of impaired drinking

  POD 1-5

Study Arms (1)

Pediatric tonsillectomy patients

All patients enrolled into study prior to undergoing tonsillectomy or adenotonsillectomy

Behavioral: Medication Tracking Form

Interventions

Medication Tracking Form BEHAVIORAL

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

Pediatric tonsillectomy patients

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: August 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)