NCT04061330

Brief Summary

The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of patient stay in the emergency department.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

August 15, 2019

Last Update Submit

April 19, 2022

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (10)

  • Clinical pain as assessed by the Numerical pain rating score (NPRS)

    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    baseline

  • Clinical pain as assessed by the Numerical pain rating score (NPRS)

    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    5 minutes after initial administration of drug

  • Clinical pain as assessed by the Numerical pain rating score (NPRS)

    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    10 minutes after initial administration of drug

  • Clinical pain as assessed by the Numerical pain rating score (NPRS)

    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    30 minutes after initial administration of drug

  • Clinical pain as assessed by the Numerical pain rating score (NPRS)

    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    60 minutes after initial administration of drug

  • Clinical pain as assessed by the Numerical pain rating score (NPRS)

    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    2 hours after initial administration of drug

  • Clinical pain as assessed by the Numerical pain rating score (NPRS)

    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    3 hours after initial administration of drug

  • Clinical pain as assessed by the Numerical pain rating score (NPRS)

    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    4 hours after initial administration of drug

  • Clinical pain as assessed by the Numerical pain rating score (NPRS)

    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    5 hours after initial administration of drug

  • Clinical pain as assessed by the Numerical pain rating score (NPRS)

    The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.

    6 hours after initial administration of drug

Secondary Outcomes (33)

  • Number of hypoxic episodes as measured with a continuous pulse oximeter

    5 minutes after initial administration of drug

  • Number of hypoxic episodes as measured with a continuous pulse oximeter

    10 minutes after initial administration of drug

  • Number of hypoxic episodes as measured with a continuous pulse oximeter

    30 minutes after initial administration of drug

  • Number of hypoxic episodes as measured with a continuous pulse oximeter

    60 minutes after initial administration of drug

  • Number of hypoxic episodes as measured with a continuous pulse oximeter

    2 hours after initial administration of drug

  • +28 more secondary outcomes

Study Arms (2)

Ketamine Group

EXPERIMENTAL
Drug: Ketamine

Opioid group

ACTIVE COMPARATOR
Drug: Morphine

Interventions

KetamineDRUG

Initial bolus of ketamine 0.3 mg/kg IV (maximum 30 mg) followed by ketamine infusion of 0.25mg/kg/hr (maximum 25mg/kg/hr) for 6 hours or until patient leaves the emergency department (ED),whichever occurs first.

Ketamine Group
MorphineDRUG

Bolus doses of morphine 0.1 mg/kg (maximum 8 mg) intravenously every 2 hours for 6 hours or until patient leaves the ED, whichever occurs first.

Opioid group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients presenting to the ED with long bone fracture, open or closed.Long bone fractures include:humerus, radius, ulna, femur, tibia, fibula.

You may not qualify if:

  • Received morphine in the ED prior to enrollment
  • Received ketamine any time prior to enrollment
  • Glasgow Coma Scale(GCS) less than 15
  • Transferred from other facility
  • Other moderate to severe trauma injuries
  • Contraindication to ketamine
  • Cannot consent (no intubation, airway issues, hemodynamic instability)
  • Prisoners
  • Suspected and/or confirmed pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

KetamineMorphine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Paulina Sergot, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 19, 2019

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)