Sub-dissociative Dose Ketamine Dosing Study

Acute Pain Clinical Trial

Official title:

A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714620
• Other study ID #: 211328
• Status: Completed
• Phase: Phase 4
• Start date: October 15, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: August 2022
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

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

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration	Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.	30 minutes
Secondary	Change in Pain Score From Baseline to 15 Minutes	Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.	15 minutes
Secondary	Change in Pain Score From Baseline to 60 Minutes	Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.	60 minutes
Secondary	Number of Participants Who Need Additional Pain Medication at 30 Minutes	Patient request for additional pain medications at 30 minutes post initiation of drug administration	30 minutes
Secondary	Number of Patients Who Need Rescue Medications at 60 Minutes	Patient request for additional pain medications at 60 minutes	60 minutes
Secondary	Adverse Effects at 30 Min	Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.	30 minutes