What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) include continuous positive airway pressure (CPAP) therapy, mandibular advancement devices, and various pharmacological agents. NSAIDs like Ketorolac, which are sometimes used to manage pain in OSA patients, have several side effects. These include gastrointestinal issues (such as ulcers and bleeding), cardiovascular risks (like increased risk of myocardial infarction), renal toxicity, and potential for acute kidney injury. Additionally, NSAIDs should be used cautiously in patients with compromised renal function or other comorbidities. While NSAIDs can reduce the need for opioid analgesics, their use is generally limited to short-term management due to these risks.

What prior FDA approvals exist?

There are no specific FDA-approved pharmacologic treatments for Obstructive Sleep Apnea (OSA) mentioned in the provided context. The context primarily discusses the use of NSAIDs like Ketorolac for postoperative pain management, which can reduce the need for opioid analgesics. While Ketorolac is being studied for its potential to decrease morphine usage in children undergoing adenotonsillectomy, this is not directly related to the treatment of OSA itself but rather to managing postoperative pain in patients with OSA.

What other types of research exist?

Promising alternatives to Ketorolac for OSA patients include newer NSAIDs like etodolac, which has shown favorable efficacy and safety in osteoarthritis treatment. Additionally, COX-2 inhibitors like celecoxib may be considered, although they carry cardiovascular risks. Non-NSAID options such as acetaminophen or combination therapies like diclofenac/misoprostol (Arthrotec) may also be viable, depending on individual patient profiles and risk factors.

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Ketorolac for Post Adenotonsillectomy Pain

Phase 4

Waitlist Available

Led By Laura Gilbertson, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of sleep disordered breathing or obstructive sleep apnea

Be younger than 65 years old

Must not have

Known renal impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes post-op, 20 minutes post-op, pacu discharge (up to 261 minutes)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Approved for 60 Other Conditions

Summary

This trial tests if ketorolac can reduce the amount of morphine needed for pain relief in children with OSA after adenotonsillectomy. Ketorolac helps manage pain and inflammation, potentially lowering the risk of opioid-related breathing issues. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that has been used to manage moderate to severe pain in various settings, including postoperative pain in children.

Who is the study for?

This trial is for children with obstructive sleep apnea undergoing adenotonsillectomy at Children's Healthcare of Atlanta Egleston. Participants must have a diagnosis of sleep disordered breathing, and their parent or guardian must consent to the study. Kids with coagulation defects, renal impairment, or on long-term NSAID therapy cannot join.

What is being tested?

The study tests if Ketorolac can reduce the need for morphine after surgery in kids with sleep apnea. It compares two groups: one receiving Ketorolac plus standard care and another getting only standard care post-adenotonsillectomy.

What are the potential side effects?

Ketorolac may cause side effects like stomach pain, bleeding, kidney problems, and allergic reactions. Since it's given to reduce opioid use (morphine), it might help lessen opioid-related side effects such as nausea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with sleep apnea or similar sleep breathing issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minutes post-op, 20 minutes post-op, pacu discharge (up to 261 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 minutes post-op, 20 minutes post-op, pacu discharge (up to 261 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes post-op, 20 minutes post-op, pacu discharge (up to 261 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Morphine

Secondary study objectives

Face, Legs, Activity, Cry, Consolability (FLACC) Scale Score

Number of Participants With Post-Tonsillectomy Bleeding

Pain Medication Administration

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active 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 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: KetorolacExperimental Treatment2 Interventions

Participants randomized to the ketorolac group will receive 0.5mg/kg IV at the end of the adenotonsillectomy procedure, once hemostasis has been achieved

Group II: Standard of CareActive Control1 Intervention

Participants randomized to this group will receive the pain management standard of care for the adenotonsillectomy procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexmedetomidine

FDA approved

Ketorolac

FDA approved

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obstructive Sleep Apnea (OSA) include Positive Airway Pressure (PAP) therapy, oral appliances, and surgical interventions. PAP therapy maintains airway patency by delivering continuous air pressure through a mask, preventing airway collapse during sleep. Oral appliances reposition the jaw or tongue to keep the airway open. Surgical interventions remove or reduce obstructive tissues in the airway. These treatments are essential as they directly address the physical obstructions causing OSA, thereby improving breathing and reducing associated health risks. While NSAIDs like ketorolac are not used to treat OSA directly, they can help manage postoperative pain and reduce opioid use following surgical treatments for OSA.