CLINICAL TRIAL

Ketorolac for Obstructive Sleep Apnea (OSA)

Recruiting · < 18 · All Sexes · Saint Louis, MO

Ketorolac on Postoperative Pain Reduction in Pediatric Patients With Adenotonsillectomy

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About the trial for Obstructive Sleep Apnea (OSA)

Eligible Conditions
Obstructive Sleep Apnea (OSA) · Sleep Disordered Breathing (SDB) · Sleep Apnea, Obstructive · Pain, Postoperative · Sleep Apnea Syndromes · Hypertrophy · Adenotonsillar Hypertrophy · Acute Post Operative Pain

Treatment Groups

This trial involves 2 different treatments. Ketorolac is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. 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.
Ketorolac
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Ketorolac
DRUG

About The Treatment

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

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adenotonsillar hypertrophy
ASA II
Otherwise healthy child
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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: two hours
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: two hours.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Ketorolac will improve 1 primary outcome in patients with Obstructive Sleep Apnea (OSA). Measurement will happen over the course of two hours.

Postoperative pain management
TWO HOURS
Change in pain score using the Wong-Baker FACES Pain Rating Scale (0-10 scale with 0 being "no hurt" and 10 being "hurts worst") and 0-10 Numeric Pain Intensity Scale (0-10 scale with 0 being "no pain" and 10 being "Worst pain").

Who is running the study

Principal Investigator
A. Z.
Prof. Andrea Zepeda, MD
St. Louis University

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 pain, postoperative?

Postoperative pain can be experienced during wound healing, at a time when an incision is open or, if an incision is not made, when a new incision is being made as necessary for the treatment. When a wound or surgical incision is painful, it may diminish the function of an arm; it may also adversely affect one's quality of life.

Anonymous Patient Answer

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

Approximately 41.1% of adults receive surgeries in the United States. Postoperative pain (40.2%) is the third most common pain that one experiences within the first 30 days after surgery with 24.3% of the patients reporting at least some pain. These pain scores are higher when patients have one or more comorbidities.

Anonymous Patient Answer

What causes pain, postoperative?

This article summarizes potential surgical risk factors influencing postoperative pain. This article also discusses common treatments to treat pain after surgery. Additional risk factors for postoperative pain are discussed as a part of the overall surgical treatment planning strategy.

Anonymous Patient Answer

What are the signs of pain, postoperative?

The major clinical presentation of pain and chronic postoperative pains may be treated using a multifactorial management approach. This approach takes into account both the patient's baseline state (demographics, psychiatric history, comorbidities and risk factors) and the characteristics of the individual pain (pain intensity and distribution). The pain and fatigue symptoms are often intertwined, sometimes with other factors such as psychological and social stress.

Anonymous Patient Answer

Can pain, postoperative be cured?

Currently, most current treatment of pain has not been successful even though this is a large problem that is being seen in the pediatric population. Pain can be treated with an aqueous solution of ketorolac topical cream. In order to be successful in reducing pain, the cream needs to be administered regularly and a schedule has to be followed. This is especially true for pain associated with surgical operations.

Anonymous Patient Answer

What are common treatments for pain, postoperative?

The most common treatment for postoperative pain is strong opioids and ketorolac. In acute pain, nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used. In chronic pain, psychosocial interventions or behavior modification techniques are usually included. A combination of medications such as analgesics, anti-inflammatory agents and muscle relaxants are usually most effective. Cognitive behavioral therapies may help some people with chronic pain.

Anonymous Patient Answer

How does ketorolac work?

The analgesic and anti-inflammatory effects of ketorolac and ketorolac tromethamine were not confirmed in post-operative pain in paediatric patients, but the results suggest the possible utility of ketorolac in paediatric patients with post-operative pain (NCT02272479).

Anonymous Patient Answer

What is the primary cause of pain, postoperative?

Pain is the most common primary cause of postoperative pain and discomfort, and nearly half of that would be attributed to pain that is not due to an identified cause. It is important to differentiate between pain that is due, attributed, and unexplained.

Anonymous Patient Answer

What is the average age someone gets pain, postoperative?

A survey of 11 American hospitals showed an average age of 64 years for postoperative pain after a [surgical procedure] but 64 years for postoperative fatigue after a [surgical procedure]. People are living longer; younger people may live longer after a [surgical procedure]. Findings from a recent study demonstrates that postoperative pain cannot be ascribed to age alone.

Anonymous Patient Answer

What are the latest developments in ketorolac for therapeutic use?

Therapeutic administration of ketorolac provides effective analgesia with few side effects in the early postoperative period. However, the use of this product is associated with an increased risk of infection and the requirement for hospital care at discharge as compared to the use of nonadverse-effect postoperative pain medication.

Anonymous Patient Answer

What are the common side effects of ketorolac?

Patients suffering from osteoporosis are prone to an increased risk of experiencing side effects of ketorolac use. Appropriate monitoring of side effects of ketorolac use in osteoporotic patients should be a routine part of its use.

Anonymous Patient Answer

What is ketorolac?

There are many reports of postoperative nausea and vomiting after ketorolac application, but the mechanisms underlying these adverse effects remain unknown. We hypothesize that ketorolac-induced vomiting results from stimulation of vagal afferent fiber pathways, which cause an increase of gastric mucosal permeability.

Anonymous Patient Answer
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