What side effects are associated with this type of intervention?

Common treatments for pain, such as ketamine, particularly at sub-dissociative doses, can cause side effects including vivid dreams, hallucinations, dizziness, and hypertension. Opioids, often used in conjunction with ketamine, can lead to nausea, constipation, sedation, and the risk of dependency. Non-opioid analgesics like NSAIDs may cause gastrointestinal issues, renal impairment, and cardiovascular risks. Topical treatments, such as those containing ketamine, may cause local irritation but generally have fewer systemic side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for pain management that act through NMDA receptor antagonism, similar to ketamine. Ketamine itself is used off-label for pain management, particularly in chronic and acute pain scenarios. Other NMDA receptor antagonists include dextromethorphan and memantine, which are primarily used for other indications but have shown some efficacy in pain management. Additionally, cannabinoids, which have been studied for their analgesic properties, are approved in various formulations for pain relief in certain countries, though not universally by the FDA.

What other types of research exist?

Promising alternatives to nebulized sub-dissociative dose ketamine for pain management include: 1) Gabapentin, which has shown efficacy in reducing cannabis use and improving cognitive function in cannabis use disorder patients, and may have applications in pain management. 2) Topical treatments containing amitriptyline and ketamine, which have shown some efficacy in improving sensory and motor symptoms in chemotherapy-induced peripheral neuropathy. 3) Intranasal ketamine, which has been evaluated for breakthrough pain in chronic pain patients and may offer a non-invasive alternative. 4) Methoxyflurane, an inhaled analgesic that has shown greater analgesia and faster onset of action in trauma pain management.

← Back to Search

NMDA Receptor Antagonist

Nebulized Ketamine for Pediatric Acute Pain

Q: What is the mechanism of action of this treatment?

Common treatments for pain work through various mechanisms to alleviate discomfort. Ketamine, particularly in sub-dissociative doses, acts as an NMDA receptor antagonist, which helps in reducing pain by blocking the excitatory neurotransmitter glutamate, thereby preventing the transmission of pain signals. This is particularly relevant for patients with refractory pain conditions where traditional analgesics may fail. Other common treatments include opioids, which bind to mu-opioid receptors in the brain and spinal cord to inhibit pain signaling, and nonsteroidal anti-inflammatory drugs (NSAIDs), which reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2). Understanding these mechanisms is crucial for pain patients as it helps in selecting the most appropriate treatment based on the type and source of pain, potentially improving pain management outcomes.

Phase 4

Waitlist Available

Research Sponsored by Antonios Likourezos

Eligibility Criteria Checklist

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

Must have

Patients with ages between 7 and 17 presenting to the ED with acute painful conditions; score of 5 or more on a standard 11-point (0 to 10) numeric rating scale

Vaso-occlusive painful crisis of sickle cell disease, and lacerations

Must not have

GCS<15

Airway abnormalities (congenital or acquired)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing a new way to give pain relief to children aged 7-17 who come to the emergency room with severe pain. Instead of using needles or pills, they will inhale a mist of ketamine, which is known to relieve pain quickly. The goal is to see if this method is safe and effective for these young patients. Ketamine has been studied as an alternative to opioids for acute pain in emergency settings, showing similar effectiveness but with short-lived side effects.

Who is the study for?

This trial is for kids aged 7-17 who come to the ED with acute pain, scoring at least a 5 on a pain scale. It includes various pains like abdominal and musculoskeletal. Kids must have taken acetaminophen or ibuprofen before getting SDK. Those with seizures, mental disorders, no parent present, pregnancy, airway issues, altered consciousness, allergy to ketamine, weight over 100 kg or high heart rate can't join.

What is being tested?

The study tests nebulized ketamine for emergency pain relief in kids when IVs aren't an option. Three doses (0.75 mg/kg, 1 mg/kg and 1.5 mg/kg) are compared to find the best one without needing needles.

What are the potential side effects?

Ketamine may cause side effects such as dizziness, nausea, mood changes or hallucinations; however specific side effects of nebulized form in this dosage range will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 7 and 17 years old and my pain score is 5 or more.

Select...

I have had painful episodes due to sickle cell disease.

Exclusion Criteria

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

Select...

My consciousness level is not fully clear.

Select...

I have a birth defect or developed issue with my airways.

Select...

I weigh more than 100 kg.

Select...

I have a seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 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

Pain Score reduction from baseline

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

Trial Design

3Treatment groups

Active Control

Group I: 0.75 mg/kgActive Control1 Intervention

The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses of 0.75 mg/kg sub-dissociative dose ketamine (SDK) to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.

Group II: SDK: 1 mg/kgActive Control1 Intervention

The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses 1 mg/kg sub-dissociative dose ketamine (SDK), to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.

Group III: SDK: 1.5 mg/kg.Active Control1 Intervention

The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses of 1.5 mg/kg sub-dissociative dose ketamine (SDK), to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.

0 / 6Eligibility 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 pain work through various mechanisms to alleviate discomfort. Ketamine, particularly in sub-dissociative doses, acts as an NMDA receptor antagonist, which helps in reducing pain by blocking the excitatory neurotransmitter glutamate, thereby preventing the transmission of pain signals. This is particularly relevant for patients with refractory pain conditions where traditional analgesics may fail. Other common treatments include opioids, which bind to mu-opioid receptors in the brain and spinal cord to inhibit pain signaling, and nonsteroidal anti-inflammatory drugs (NSAIDs), which reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2). Understanding these mechanisms is crucial for pain patients as it helps in selecting the most appropriate treatment based on the type and source of pain, potentially improving pain management outcomes.

"Burst" ketamine for refractory cancer pain: an open-label audit of 39 patients.