CLINICAL TRIAL

Acetaminophen/APAP for Pain

Waitlist Available · < 18 · All Sexes · Washington, United States

This study is evaluating how acetaminophen is released into the urine and blood; how the blood levels of acetaminophen and its breakdown products affect the preterm infant's health; and how the genetic make-up or characteristics affect how acetaminophen

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About the trial for Pain

Treatment Groups

This trial involves 2 different treatments. Acetaminophen/APAP 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 2 & 3 and have had some early promising results.

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

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Preterm and term neonates of both genders and all races
a postnatal age of less than 28 days
GA's of from 22 to less than 37 weeks
an indwelling (peripheral or umbilical) arterial line
a clinical indication for intravenous administration of pain relief medication
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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: 48 hours
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 hours
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 48 hours.
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- 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 Acetaminophen/APAP will improve 1 primary outcome and 1 secondary outcome in patients with Pain. Measurement will happen over the course of 48 hours.

primary endpoint PK analysis
48 HOURS
Blood and urine levels of APAP and metabolites
48 HOURS
Developmental stage
48 HOURS
To assess both the magnitude and statistical significance of any evidence of relationship between developmental stage and toxicity-associated metabolite levels. The analyses will also hold constant APAP dose, BID or TID and possible confounding variables such as birth order, maternal smoking status, and maternal age. We will plot the relationship between stage of development and measures of APAP Metabolism, taken at different gestational and postnatal ages. A hierarchical, cross sectional time series models will be used.
48 HOURS

Patient Q & A Section

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

How many people get pain a year in the United States?

About 35 million elderly people in the United States have no health insurance. Inadequate pain control is associated with several comorbid disorders. Furthermore, nonmedical use of prescription medications such as opioids and narcotics are common in elderly patients at high risk for opioid-related adverse events. Effective pain control programs are most important for elderly patients.

Anonymous Patient Answer

What are the signs of pain?

A patient's description of his or her pain and pain relief from a medication may be useful information. Other information to look for is how the pain is felt, intensity, duration of pain episodes and any changes to sleep or usual activities.

Anonymous Patient Answer

What causes pain?

Pain has a multitude of underlying causes. These causes range from the pain experienced during childbirth and the flu to major pathology in bones and organs. A physician must be aware of both acute and chronic chronic pain, such as chronic musculoskeletal pain, and must treat the pain appropriately to relieve it. Topics covered include the diagnosis and treatment of pain and the role of medication.

Anonymous Patient Answer

What are common treatments for pain?

Pain is commonly treated with medications such as acetaminophen (paracetamol) and nonsteroid anti-inflammatory drugs (NSAIDs). Many patients are also prescribed opioids, such as ketorolac. If their underlying pathology worsens, these patients are prescribed other analgesics like phencyclidine and tramadol. For severe cases, some patients are also treated with antidepressants. Patients presenting to a pain clinic may be screened for more serious medical conditions.\n

Anonymous Patient Answer

What is pain?

Pain is one of the most important dimensions in the conceptualization of the [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) experience, in that it contributes to the intensity of, the duration of, the consequences of, and the perceived threat the experience. Clinically, the pain experience is represented by the two attributes "pain quality of life" and "pain frequency". "Pain quality of life" is the attribute of pain intensity that constitutes the pain experience, while...

Anonymous Patient Answer

Can pain be cured?

Pain is one aspect of a complex disease; many of the treatments described in this article can, after an experience of long term (years), no longer have a marked effect on the pain. In particular, no drug that reduces morphine consumption has yet been shown to do so, particularly when compared to placebo, i.e. when pain is being controlled effectively. Most patients respond to treatment and it can be said that a significant proportion of them will not feel pain when they are healed, but this tends to happen only to certain patients, and not to all.

Anonymous Patient Answer

Does acetaminophen/apap improve quality of life for those with pain?

Participants using acetaminophen/apap demonstrated a significantly greater improvement in pain and function than those not using this medication. The combination of acetaminophen or morphine and apap is a safe and effective therapy for persons with multiple-site pain.

Anonymous Patient Answer

What is the average age someone gets pain?

Although a large part of our study participants' reported pain was chronic, the average age at reporting pain onset was approximately 45.2 years. This age disparity suggests the need for initiatives to acknowledge the importance of pain as a concern at earlier ages. Findings from a recent study also suggest that inpatients should include a question regarding age at pain onset when reporting new ailments among their complaints to family physicians.

Anonymous Patient Answer

What does acetaminophen/apap usually treat?

Most patients take acetaminophen/apap for their [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain), such as back pain, headache, arthritis, or pain from a sprained ankle. A minority take it for stomach or colon pains. However, the effectiveness of this combination is uncertain. In some patients, acetaminophen/apap may cause dangerous side effects in patients with gastrointestinal or liver problems. It is not for people with glaucoma or severe or painful menstruation.

Anonymous Patient Answer

How serious can pain be?

The pain scale is a good measure of the seriousness of pain although there are some discrepancies between how the questionnaire is interpreted (severity only) and how the patient interprets the answers to questions of which he or she has been asked (severity all). There is an urgent need for standardized self-report measures of the seriousness of pain.

Anonymous Patient Answer

What are the common side effects of acetaminophen/apap?

The most common adverse effects associated with APAP/APAP abuse included gastrointestinal issues and dizziness. Acute liver injury may occur with overdoses of APAP or APAP/APAP combination and may be life-threatening.

Anonymous Patient Answer

What is the primary cause of pain?

The primary causes of pain vary somewhat according to what is being looked for. One must take into account the history of the patient, the physical exam, and then look for the cause of the pain. Pain is usually a result of a number of different factors and none is more important than others. The most important cause should be looked for, then tried to be corrected if necessary.

Anonymous Patient Answer
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