CLINICAL TRIAL

Ibuprofen for Humeral Fractures

Recruiting · < 18 · All Sexes · Los Angeles, CA

This study is evaluating whether a combination of acetaminophen and ibuprofen or acetaminophen and oxycodone is more effective for pain control in children with closed supracond

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About the trial for Humeral Fractures

Eligible Conditions
Fractures, Bone · Supracondylar Humerus Fractures · Humeral Fractures

Treatment Groups

This trial involves 2 different treatments. Ibuprofen is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ibuprofen
DRUG
Acetaminophen
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Oxycodone
DRUG
Acetaminophen
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen
FDA approved
Acetaminophen
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
This is a fracture of the humerus above the elbow. show original
Type II fractures are minimally displaced and involve less than one-third of the articular surface show original
had a significantly higher union rate than those treated with open reduction and percutaneous pinning show original
Closed supracondylar humerus fracture
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Immediately after surgery at time of randomization until the patient returns for 1st post-operative visit, 7-10 days post-operatively, assessed up to 10 days.
Screening: ~3 weeks
Treatment: Varies
Reporting: Immediately after surgery at time of randomization until the patient returns for 1st post-operative visit, 7-10 days post-operatively, assessed up to 10 days.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Immediately after surgery at time of randomization until the patient returns for 1st post-operative visit, 7-10 days post-operatively, assessed up to 10 days..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ibuprofen will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Humeral Fractures. Measurement will happen over the course of 1 week at first post-operative follow-up.

Total Quality Pain Management Instrument
1 WEEK AT FIRST POST-OPERATIVE FOLLOW-UP
Questionnaire used to measure the quality of children's post-operative pain management in which parents and patients are asked multiple questions re: post-operative pain management including domains in pain experience, pain relief, adverse effects, future analgesic use. The majority of the questions are binary, but there are a few questions that include a mild, moderate, severe option. There is no numerical output, and the subscales are not combined.
1 WEEK AT FIRST POST-OPERATIVE FOLLOW-UP
Faces Pain Scale-Revised (FPSR)
24 TO 48 HOURS POST-OPERATIVELY
Self reported measure of pain on scale 0-10. 0 = no pain; 10 = worst pain imaginable
24 TO 48 HOURS POST-OPERATIVELY
Pain medication logs
IMMEDIATELY AFTER SURGERY AT TIME OF RANDOMIZATION UNTIL THE PATIENT RETURNS FOR 1ST POST-OPERATIVE VISIT, 7-10 DAYS POST-OPERATIVELY, ASSESSED UP TO 10 DAYS.
Self report take home medication logs recording the time, type, dosage, and side effects of medication
IMMEDIATELY AFTER SURGERY AT TIME OF RANDOMIZATION UNTIL THE PATIENT RETURNS FOR 1ST POST-OPERATIVE VISIT, 7-10 DAYS POST-OPERATIVELY, ASSESSED UP TO 10 DAYS.

Who is running the study

Principal Investigator
R. T.
Rachel Thompson, MD
University of California, Los Angeles

Patient Q & A Section

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

What is humeral fractures?

Humeral fractures are common. In the UK they are the fifth commonest bone fracture. They are often the result of a fall, but can also be seen in car accidents, assaults and sports injuries. A careful history, especially regarding the date, time, place and activity is helpful in making the correct diagnosis. The presence of pain (especially with rotation), numbness and deformity should prompt the diagnosis of a fracture. Radiography has limited value in the diagnosis of fractures and should be restricted to those cases where the diagnosis is being considered clinically.

Anonymous Patient Answer

What causes humeral fractures?

More than 80% of cases are due to child abuse and in the age groups of 5–7 years and 25–39 years. It can therefore be concluded that the incidence of fractures has increased in parallel with increasing child abuse rates. In the first 8 years after childbirth, the fracture rate has risen sharply due to the high risk of broken bones resulting from labour, particularly in young mothers. In the age groups of 5–7 and 25-39 years, the risk from falling is increased in the summer in all countries. The risk due to motor vehicle traffic accidents is also great. In older populations, the risk of breaking bones is due to osteoporosis and related disorders.

Anonymous Patient Answer

What are common treatments for humeral fractures?

In this cohort of patients at a level I trauma center, the use of plate fixation for humeral fractures was infrequently used. Fractures requiring surgical treatment were most frequently treated with open or closed reduction and screw fixation. The complication rate was 2%, which suggests that open/closed reduction and screw fixation with plate fixation is an acceptable intervention for patients with humerus fractures.

Anonymous Patient Answer

How many people get humeral fractures a year in the United States?

Approximately 50.8 million injuries to the upper extremities occur annually in USA. Around 1.33 million fractures will occur from these injuries. The number of fractures in adults is higher than that in children (9.9 vs. 6.4 %). The fractures occur both in the proximal (knee/elbow and proximal humerus) and distal (scapula, foot) sites. Trauma patterns in the USA show that most (94 %) road traffic injuries and fall-related injuries occur in adult populations. The most commonly fractured bones are the proximal humerus, femur, tibia, and ankle. In men, over 50 % of fractures occur in the proximal humerus.

Anonymous Patient Answer

What are the signs of humeral fractures?

Signs of humeral fractures include: loss of pain, inability to resist force, decreased range of motion, radial deviation and tenderness, radial nerve deviation and subacromial swelling. Radial nerve dysfunction and swelling are also frequently associated. The radial nerve can be at risk for injury during shoulder surgery but the use of a 'tilt' position may avoid nerve injury.

Anonymous Patient Answer

Can humeral fractures be cured?

With appropriate treatment, most fractures heal without permanent damage or deformity; however, with improper treatment, a fracture can rarely heal and result in permanent joint damage and deformity.

Anonymous Patient Answer

How does ibuprofen work?

Ibuprofen is an effective treatment for pain, but it is also used for other purposes, including inflammation, fever, and fever-reducing drugs. Ibuprofen also has effects on the central nervous system, by enhancing the sensation of pain. It is unclear how ibuprofen affects fractures. We do not know whether it is safe to use ibuprofen during pregnancy or whether it might harm the baby. We also do not know if ibuprofen affects the function of the baby if it is used during the early years of life.

Anonymous Patient Answer

Is ibuprofen safe for people?

No evidence supports the use of paracetamol to prevent postoperative shoulder pain. If your symptoms do not improve after 4-10 days, call your doctor. When shoulder pain remains after 4-10 days, see your GP for pain relief.

Anonymous Patient Answer

Have there been other clinical trials involving ibuprofen?

The majority of the studies that have been published in journals have been small. Based upon our search results to identify relevant clinical trials, there is little evidence that there is any significant benefit from Ibuprofen use in non-arthritic conditions. However, it is clear that a large amount of research is needed to draw any firm conclusions.

Anonymous Patient Answer

What is the primary cause of humeral fractures?

Among our patients, more than 85% of fractures occurred by trauma, with a history of trauma suggestive of a significant risk factor. The most common fractures were to the clavicle or sternum. A history of falling from an upright position was the most common complaint (53%) for fractures in the humerus.

Anonymous Patient Answer

What are the common side effects of ibuprofen?

Ibuprofen appears to be well tolerated and well tolerated. However, serious side effects are rare in this patient population and may include [liver toxicity, allergic reactions, and nephrotoxicity] and those that occur are usually mild. The FDA now requires that manufacturers include these side effects on their product information labels. Ibuprofen is commonly prescribed and is considered effective at the prescribed dosage. It should be used in patients for whom it is considered and discussed in the appropriate light with an ophthalmologist or optometrist, who will monitor patient care, prescribe the drug, and advise patients of all side effects.

Anonymous Patient Answer

What does ibuprofen usually treat?

We have identified a surprisingly large range of problems which ibuprofen seems to often treat under its common name of "ibuprofen." Most of these conditions are unlikely, nor is there any evidence that pain relief is an important benefit of treatment with these drugs. Therefore, we recommend that ibuprofen's analgesic properties to be regarded with much less confidence than is usually done. If any other benefit of ibuprofen is of interest, it is unclear whether that benefit is clinically important. There is an emerging evidence base for the efficacy of ibuprofen against migraine.

Anonymous Patient Answer
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