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NSAIDs vs Opioids for Post-op Pain in Broken Arms
Study Summary
This trial will compare the pain-relieving effects of acetaminophen + ibuprofen to those of acetaminophen-hydrocodone in children with broken elbows who need surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am having a specific arm bone fracture fixed without open surgery.I have liver or kidney disease.I was diagnosed with reduced blood flow or pressure build-up in my muscles upon hospital admission.I have a history of bleeding disorders.I have been diagnosed with juvenile arthritis.I have been taking NSAIDs or opioids regularly before the procedure.I have a bleeding disorder or had open fractures or other major injuries when diagnosed.
- Group 1: Control
- Group 2: Treatment
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the upper limit for participant enrollment in this trial?
"Affirmative. According to the information on clinicaltrials.gov, this medical study is currently seeking participants; it was first posted on June 7th 2021 and last modified on September 9th 2021. This research endeavour requires 150 individuals from a single site."
Does this clinical research currently have vacancies available for participants?
"Affirmative. Information on clinicaltrials.gov indicates that recruitment for this trial is in progress and has been since June 7th 2021, with the last edit being made on September 9th 2021. The project requires 150 people to register from one site."
Are there any additional experiments that have been conducted regarding Acetaminophen and Ibuprofen?
"Currently, 109 trials are investigating the efficacy of Acetaminophen and Ibuprofen. 32 of them have advanced to Phase 3. Although most studies are located in Pittsburgh, Pennsylvania, there is a total of 1033 sites running related experiments on this medication."
What is the regulatory status of Acetaminophen and Ibuprofen in terms of governmental approval?
"Acetaminophen and Ibuprofen have already been approved, so it was rated a 3 on our team's safety scale."
To what population is this research open?
"Researchers are currently seeking 150 minors aged 4-13 with isolated supracondylar humerus fractures requiring closed reduction and percutaneous pinning (CRPP)."
Is the eligibility for this trial restricted to those under 60 years of age?
"To be enrolled in this trial, participants must range between 4 to 13 years old. Furthermore, there are 105 studies involving individuals below the age of majority and 356 trials for elderly patients over 65."
What medical concerns are Acetaminophen and Ibuprofen usually prescribed for?
"Acetaminophen and Ibuprofen are viable treatments for catarrh, rhinorrhea, and musculoskeletal pain."
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