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Completed

NCT Number: NCT03714620

Sub-dissociative Dose Ketamine Dosing Study

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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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

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

Primary outcomes

  1. Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration

    Time frame: 30 minutes

    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.

Secondary outcomes

  1. Change in Pain Score From Baseline to 15 Minutes

    Time frame: 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.

  2. Change in Pain Score From Baseline to 60 Minutes

    Time frame: 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.

  3. Number of Participants Who Need Additional Pain Medication at 30 Minutes

    Time frame: 30 minutes

    Patient request for additional pain medications at 30 minutes post initiation of drug administration

  4. Number of Patients Who Need Rescue Medications at 60 Minutes

    Time frame: 60 minutes

    Patient request for additional pain medications at 60 minutes

  5. Adverse Effects at 30 Min

    Time frame: 30 minutes

    Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2018
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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