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Pain Management
Analgesic Regimens for Surgical Pain (CARES for Kids Trial)
Phase 4
Waitlist Available
Led By Mark Bicket, MD, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No significant analgesic medication use before surgery as defined in the protocol
Undergo one of the following procedures: elective tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), or knee scope (arthroscopy)
Must not have
Patients with contraindications to non-steroidal anti-inflammatory drug (NSAID) drugs in the NSAID arm, opioid drugs in the opioid arm, or acetaminophen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3, 1 week, and 2 weeks after surgery
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial aims to compare two different pain treatment options for patients who have had tonsil removal, gallbladder removal, or knee scope surgery. Participants will be randomly assigned to receive either Non-Ster
Who is the study for?
This trial is for kids who've had tonsillectomies, gallbladder removals, or knee scopes. They'll be randomly assigned to one of two pain management groups after surgery: NSAIDs with acetaminophen or a low dose opioid combined with NSAIDs and acetaminophen.
What is being tested?
The study compares the effectiveness and safety of two post-surgery pain treatments in children. One group will receive non-opioid drugs (NSAIDs plus acetaminophen), while the other will get a combination including a low-dose opioid.
What are the potential side effects?
Possible side effects may include stomach upset or bleeding from NSAIDs, liver damage from too much acetaminophen, and constipation, nausea, or breathing issues from opioids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't used strong painkillers before surgery.
Select...
I am scheduled for elective tonsil, gallbladder, or knee surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can safely take NSAIDs, opioids, and acetaminophen without any health risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 3, 1 week, and 2 weeks after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3, 1 week, and 2 weeks after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery
Safety outcome - number and severity of any adverse medication-related symptoms over 14 days post-surgery
Secondary study objectives
Acute pain based on The Michigan Body Map
Analgesic medication use
Brief Screening Instrument for Adolescent Tobacco, Alcohol, and Drug Use
+13 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Acetaminophen/NSAID/Opioid regimenExperimental Treatment3 Interventions
Group II: Acetaminophen/NSAID regimenExperimental Treatment2 Interventions
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
Opioid
2008
Completed Phase 4
~2450
NSAID
2016
Completed Phase 4
~10200
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,860 Previous Clinical Trials
6,437,020 Total Patients Enrolled
7 Trials studying Surgery
5,014,181 Patients Enrolled for Surgery
Patient-Centered Outcomes Research InstituteOTHER
576 Previous Clinical Trials
27,078,787 Total Patients Enrolled
3 Trials studying Surgery
13,700 Patients Enrolled for Surgery
Mark Bicket, MD, PhDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
1,000 Total Patients Enrolled
2 Trials studying Surgery
1,000 Patients Enrolled for Surgery