An observational study in Pain, Postoperative and Obstructive Sleep Apnea of Child, sponsored by Oregon Health and Science University. Status unknown at 1 site in United States. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-04-16.
Sponsored by Oregon Health and Science University · Observational
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.
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 470 are open to participants now.
This study's planned enrollment of 100 is close to the median of 104 across 648 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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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
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.
Time frame: POD 1-5
Mean Worst Pain Scores POD 1-5
Average of worst pain scores as documented twice a day on POD 1-5
Time frame: POD 1-5
Total acetaminophen administered on POD 1-5
Total acetaminophen given (total dose and total quantity as mg/kg)
Time frame: POD 1-5
Total ibuprofen administered on POD 1-5
Total ibuprofen given (total dose and total quantity as mg/kg)
Time frame: POD 1-5
Frequency of Vomiting on POD 1-5
Number of days vomiting on POD 1-5
Time frame: POD 1-5
Duration of impaired drinking
Return to normal drinking on POD 1-5
Time frame: POD 1-5
Duration of impaired eating
Return to normal eating on POD 1-5
Time frame: POD 1-5
Duration of impaired activity
Return to normal activity on POD 1-5
Time frame: POD 1-5
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University