NCT02916927

Brief Summary

Objective: The purpose of this study is to determine if administering ketamine as an intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse drug reactions without attenuating its analgesic effects. Study design: prospective, randomized, controlled, double-blind trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 17, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

September 26, 2016

Results QC Date

March 22, 2020

Last Update Submit

April 4, 2020

Conditions

Pain

Keywords

ketamineemergency department

Outcome Measures

Primary Outcomes (1)

  • Side Effects

    The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes.

    0 - 60 minutes

Secondary Outcomes (4)

  • Side Effects

    5, 10, 15, 20, 30, 45, 60 minutes

  • Side Effect Severity

    5, 10, 15, 20, 30, 45, 60 minutes

  • How Bothersome Are the Side Effects?

    5, 10, 15, 20, 30, 45, 60 minutes

  • Reduction in Pain on Numeric Rating Scale.

    5, 10 , 15, 20, 30, 45, 60 minutes

Study Arms (2)

Ketamine IV infusion

EXPERIMENTAL

Ketamine 0.3 mg/kg in 100 mL normal saline minibag infused over 15 minutes. Placebo: 10 mL normal saline in syringe pushed over 1 minute. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.

Drug: Ketamine IV Infusion

Ketamine IV push

ACTIVE COMPARATOR

Ketamine 0.3 mg/kg in a syringe pushed over 1 minutes. Placebo: 100 mL normal saline minibag infused over 15 minutes. Masking: placebo normal saline minibags and placebo syringes will appear identical to the normal saline minibus and syringes with ketamine.

Drug: Ketamine IV push

Interventions

Ketamine IV InfusionDRUG

Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.

Also known as: Ketalar
Ketamine IV infusion
Ketamine IV pushDRUG

Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.

Also known as: Ketalar
Ketamine IV push

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain NRS ≥5
  • Anticipated stay in ED ≥1 hour

You may not qualify if:

  • Pregnant or breast feeding
  • Vital sign abnormalities (SBP \<90, SBP \> 180, HR \< 50, HR \> 150, RR \<10, RR \> 30, weight \<45 kg, weight \> 115 kg)
  • Arrhythmias
  • Altered mental status (active psychosis/delirium)
  • Administration of opioid pain medication in previous 1 hour
  • history of acute head or ocular trauma
  • presence of known intracranial mass or vascular lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alameda Health System, Highland Hospital

Oakland, California, 94602, United States

Location

Related Publications (1)

  • Clattenburg EJ, Hailozian C, Haro D, Yoo T, Flores S, Louie D, Herring AA. Slow Infusion of Low-dose Ketamine Reduces Bothersome Side Effects Compared to Intravenous Push: A Double-blind, Double-dummy, Randomized Controlled Trial. Acad Emerg Med. 2018 Sep;25(9):1048-1052. doi: 10.1111/acem.13428. Epub 2018 May 25.

    PMID: 29645317DERIVED

MeSH Terms

Conditions

PainEmergencies

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Andrew Herring
Organization
Alameda Health Systemt - Highland Hospital
aherring@alamedahealthsystem.org
(510) 437-4564

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 17, 2020

Results First Posted

April 17, 2020

Record last verified: 2020-04

Locations

US(1)