← Back to Search

Non-Opioid Pain Medication for Post-Surgery Pain

Phase 1 & 2

Waitlist Available

Led By David H Chi, MD

Research Sponsored by David Chi, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two months post-operatively

Awards & highlights

Study Summary

This trial is testing if it's safe to use non-opioid drugs for pain control after a common childhood surgery.

Who is the study for?

This trial is for children aged 3-17 undergoing adenotonsillectomy. It's not suitable for those who are pregnant, allergic to study medications, unable to communicate pain, or on opioids during enrollment. Caregivers must be proficient in English.Check my eligibility

What is being tested?

The study compares non-opioid pain control with a combination of opioid and non-opioid medications after intracapsular adenotonsillectomy in children. Participants are randomly assigned to one of the two groups to assess pain management effectiveness.See study design

What are the potential side effects?

Possible side effects include reactions specific to acetaminophen or ibuprofen such as stomach upset, bleeding risk from ibuprofen, and potential addiction or respiratory issues related to oxycodone use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and two months post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average pain burden

Secondary outcome measures

ED (Emergency Department) or urgent care visits

Other outcome measures

Duration of each analgesic used

Education level

Frequency of each analgesic used

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Opioid pain control + Disposal PouchExperimental Treatment5 Interventions

Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary or by email/mail if no appointment was scheduled. Half of the families randomized to the opioid group will be further randomized to receive an opioid disposal bag + an opioid disposal education document. The pouch is a drug deactivation disposal pouch to dispose the opioid at home.

Group II: Opioid pain controlExperimental Treatment4 Interventions

Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary or by email/mail if no appointment was scheduled. Families will receive an opioid disposal education document.

Group III: Non-opioid pain controlActive Control2 Interventions

Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary or by email/mail if no appointment was scheduled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetaminophen

2017

Completed Phase 4

~2030

Ibuprofen

2013

Completed Phase 4

~5800

Oxycodone

2014

Completed Phase 4

~2210

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

David Chi, MDLead Sponsor

3 Previous Clinical Trials

869 Total Patients Enrolled

David H Chi, MDPrincipal InvestigatorClinical Director, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh

2 Previous Clinical Trials

654 Total Patients Enrolled

Media Library

Acetaminophen Clinical Trial Eligibility Overview. Trial Name: NCT04791761 — Phase 1 & 2

Postoperative Analgesia Research Study Groups: Non-opioid pain control, Opioid pain control, Opioid pain control + Disposal Pouch

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the utilization of Oxycodone in medical research been previously explored?

"Currently, 121 research initiatives are exploring the medical properties of Oxycodone. Of these studies, 34 have reached Phase 3 trials. A significant portion of these clinical experiments take place in Pittsburgh, but there is a total of 1046 locations conducting tests for Oxycodone across the world."

Answered by AI

What maladies generally benefit from Oxycodone treatment?

"Oxycodone is a common treatment for catarrh, but it may also help with rhinorrhoea, musculoskeletal pain, and muscular spasms."

Answered by AI

How many individuals have enrolled in this research endeavor?

"Positive. Information available on clinicaltrials.gov alludes to the fact that this medical experiment is currently looking for volunteers and has been since April 13th 2021, when it was first posted. A total of 300 participants are needed from a single site."

Answered by AI

Does this trial accommodate participants aged 18 or above?

"This trial is seeking out participants aged 3 to 17 and the eligibility requirements for this age bracket are described in-depth. Furthermore, there are 60 trials that target those below 18 years of age and 222 studies tailored towards individuals over 65."

Answered by AI

Am I able to become a volunteer for this medical experiment?

"For this project, 300 minors aged 3-17 with an opioid dependency are being recruited. Eligibility is notably contingent on these individuals undergoing a tonsil and adenoid removal procedure."

Answered by AI

Is enrollment currently available for this experiment?

"As per information housed on clinicaltrials.gov, this medical investigation is actively recruiting participants. The trial was initially posted to the website in April 2021 and has since been updated several times, with the latest revision taking place in March 2022."

Answered by AI

Recent research and studies

MMWR. Morbidity and Mortality Weekly ReportJournal

Increases in Drug and Opioid-involved Overdose Deaths — United States, 2010–2015

Rudd, Rose A., Puja Seth, Felicita David, and Lawrence Scholl. 2016. “Increases in Drug and Opioid-involved Overdose Deaths — United States, 2010–2015”. MMWR. Morbidity and Mortality Weekly Report. Centers for Disease Control MMWR Office. doi:10.15585/mmwr.mm655051e1.

JamaJournal

New Data on Opioid Use and Prescribing in the United States

Schuchat, Anne, Debra Houry, and Gery P. Guy Jr. 2017. “New Data on Opioid Use and Prescribing in the United States”. Jama. American Medical Association (AMA). doi:10.1001/jama.2017.8913.

Anesthesia & AnalgesiaJournal

Opioid Prescribing for the Treatment of Acute Pain in Children on Hospital Discharge

Monitto, Constance L., Aaron Hsu, Shuna Gao, Paul T. Vozzo, Paul S. Park, Deborah Roter, Gayane Yenokyan, et al.. 2017. “Opioid Prescribing for the Treatment of Acute Pain in Children on Hospital Discharge”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000002586.

Anesthesia & AnalgesiaJournal