Sub-dissociative Dose Ketamine Dosing Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-09-17

Brief Summary

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Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.

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Detailed Description

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Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups.

Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All study investigators, patients and clinicians except the clinical pharmacist will be blinded to the study treatment allocation. Treatment will be prepared and blinded by the ED clinical pharmacist.

Study Groups

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0.15 mg/kg IV Ketamine

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes

0.3 mg/kg IV Ketamine

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes

Interventions

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Ketamine

Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults ages 18-59
* Weight 45 - 115 kg
* Acute abdominal, flank, back, musculoskeletal pain, or a headache
* Onset of pain within 7 days
* Pain score of 5 or more
* Requiring intravenous analgesia
* Hasn't been enrolled in this study previously

Exclusion Criteria

* Pregnancy
* Breast-feeding
* Altered mental status rendering the patient unable to consent to the study
* Allergy to ketamine
* Unstable vital signs (systolic blood pressure \<90 or \>180 mm Hg, pulse rate \<50 or \>150 beats/minute, and respiration rate \<10 or \>30 breaths/minute)
* History of acute head or eye injury, seizure, intracranial hypertension
* Chronic pain
* Renal or hepatic insufficiency
* Known alcohol or drug use disorder
* Currently under influence of alcohol/opiates
* Acute psychiatric illness

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes