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Compares treatment options for Surgery
Official title Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
ClinicalTrials.gov ID: NCT06671002
What this study is testing
What is NSAID?
NSAID is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for surgery.
Also referred to as Ibuprofen, Celecoxib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is being completed to compare two commonly used options to treat pain after discharge from surgery. Participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 20
You may be able to join if
- No significant analgesic medication use before surgery as defined in the protocol. For this study, we define significant analgesic medication use...
- Undergo one the following: tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).
You likely can't join if
- Anticipated other surgery within 12 months
- Anticipated life expectancy of \<12 months
- Those that have legal guardians (due to special permission to enroll in trials)
- Participants with complex chronic conditions per the Pediatric Medical Complexity Algorithm (e.g., trisomy 21)
- Patients with contraindications to non-steroidal anti-inflammatory drug (NSAID) drugs in the NSAID arm, opioid drugs in the opioid arm, or...
- Liver disease
See the full eligibility criteria
- No significant analgesic medication use before surgery as defined in the protocol. For this study, we define significant analgesic medication use before surgery as prescriptions reported by the child or caregiver for 6...
- Undergo one the following: tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).
- Anticipated other surgery within 12 months
- Anticipated life expectancy of \<12 months
- Those that have legal guardians (due to special permission to enroll in trials)
- Participants with complex chronic conditions per the Pediatric Medical Complexity Algorithm (e.g., trisomy 21)
- Patients with contraindications to non-steroidal anti-inflammatory drug (NSAID) drugs in the NSAID arm, opioid drugs in the opioid arm, or acetaminophen will be excluded.
- Liver disease
- Acute psychiatric instability (defined as current uncontrolled severe depression, severe post-traumatic stress disorder (PTSD), or suicidal ideation), substance use disorder not in remission or treatment, and history of...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Palo Alto, California, United States
- Ann Arbor, Michigan, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Palo Alto, California, United States; Ann Arbor, Michigan, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.