Ketamine as a Supplement to Local Anesthesia for Minor Procedures
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age7-70
SponsorLoyola University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Undergoing Minor Procedure in the ED
Weight not to exceed 115kg
Disqualifiers
Altered Mental Status
Pregnancy
Breastfeeding
Acute head or eye injury
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine
DrugKetamine is an N-methyl-D aspartate receptor agonist
Saline
Other interventionIntranasal saline flushes pollen, dust, and other debris from nasal passages. It also removes excess mucus and adds moisture
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Intranasal KetamineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Immediate pain
Pain will be measured using the numeric rating scale which is a scale ranging from 0 to 100, where higher values report greater pain
Time frame
15 minutes2
Acute pain
Pain will be measured using the numeric rating scale which is a scale ranging from 0 to 100, where higher values report greater pain
Time frame
30 minutes3
Delayed pain
Pain will be measured using the numeric rating scale which is a scale ranging from 0 to 100, where higher values report greater pain
Time frame
60 minutesSecondary outcomes
1
Immediate agitation
For adults, agitation will be measured using the Richmond Agitation Sedation Scale (RASS) which is a 10-point scale (range: -5 to +4), where higher scores reflect greater agitation.
Time frame
15 minutes2
Acute agitation
For adults, agitation will be measured using the Richmond Agitation Sedation Scale (RASS) which is a 10-point scale (range: -5 to +4), where higher scores reflect greater agitation.
Time frame
30 minutes3
Delayed agitation
For adults, agitation will be measured using the Richmond Agitation Sedation Scale (RASS) which is a 10-point scale (range: -5 to +4), where higher scores reflect greater agitation.
Time frame
60 minutes4
Immediate alertness
For pediatric patients, agitation will be measured using the University of Michigan Sedation Scale (UMSS) which assesses the level of alertness on a five-point scale ranging from 0 (awake and alert) to 4 (unarousable).
Time frame
15 minutesSponsors and contacts
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Source ClinicalTrials.gov