NCT06284473 Ketamine as a Supplement to Local Anesthesia for Minor Procedures
| NCT ID | NCT06284473 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Loyola University |
| Condition | Pain, Procedural |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2022-05-25 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 108 participants in total. It began in 2022-05-25 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial is a double-blind randomized controlled clinical trial of adults and children (ages 7 to less than 70 years). Patients who present to the ED and who undergo minor bedside procedures that require local anesthesia will be divided into two groups: The first group will be treated with 0.7 mg/kg intranasal ketamine as well as standard local anesthesia for the procedure (treatment cohort). The second group will be treated with a volume-based dose of intranasal saline solution as well as standard local anesthesia for the procedure (control cohort). The primary aim is to assess whether patients in the treatment cohort report lower pain scores on the Numerical Rating Scale (NRS-100) when compared to patients in the control cohort. For adult patients, a secondary aim is to compare agitation between the two cohorts using the Richmond Agitation Sedation Scale (RASS) and, for pediatric patients, a secondary aim is to compare alertness between the two cohorts using the University of Michigan Sedation Scale (UMSS). Results obtained from specific procedures will be analyzed on a spectrum of complexity and general length of recovery time. Scientific achievements may include finding a safe and effective way to reduce pain and discomfort during minor procedures in the Emergency Department. Additionally, it would provide opportunities for more research on sub-dissociative doses of ketamine during minor procedures: a topic in which there is still a gap in the published research
Eligibility Criteria
Inclusion Criteria: * Undergoing Minor Procedure in the ED * Weight not to exceed 115kg Exclusion Criteria: * Altered Mental Status * Pregnancy * Breastfeeding * Acute head or eye injury * Intercranial Hypertension * Hx of seizures * Hx of chronic pain * Unstable vital signs * Allergy to Ketamine * Hepatic or Renal Insufficiency * Hx of Psychiatric Illness * Hx of alcohol/drug abuse
Contact & Investigator
Trent Reed, DO
PRINCIPAL INVESTIGATOR
Loyola University
Frequently Asked Questions
Who can join the NCT06284473 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 70 Years, studying Pain, Procedural. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06284473 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06284473 currently recruiting?
Yes, NCT06284473 is actively recruiting participants. Contact the research team at slovett@lumc.edu for enrollment information.
Where is the NCT06284473 trial being conducted?
This trial is being conducted at Maywood, United States.
Who is sponsoring the NCT06284473 clinical trial?
NCT06284473 is sponsored by Loyola University. The principal investigator is Trent Reed, DO at Loyola University. The trial plans to enroll 108 participants.