NCT00195910

Brief Summary

To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for phase_2 pain

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_2 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

October 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

September 12, 2005

Last Update Submit

August 13, 2018

Conditions

Pain

Keywords

AcutePainEmergency DepartmentMorphineHydromorphoneDilaudidoligoanalgesia

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity from baseline to 30 minutes after medications were infused.

    Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable)

    baseline to 30 minutes after medication infused

Secondary Outcomes (9)

  • Pain intensity 5 minutes after medication is given

    5 minutes after medication is given

  • Pain intensity 30 minutes after medication is given

    30 minutes after medication is given

  • Pain intensity 2 hours after medication is given

    2 hours after medication is given

  • Number of participants experiencing vomiting between baseline to 5 minutes after medication is given

    baseline to 5 minutes after medication is given

  • Number of participants experiencing vomiting between 6 minutes after medication is given to 30 minutes after medication is given

    6 minutes after medication is given to 30 minutes after medication is given

  • +4 more secondary outcomes

Study Arms (2)

Morphine

ACTIVE COMPARATOR

single dose of intravenous (IV) morphine, 0.1 mg/kg intervention: 0.1 mg/kg IV morphine

Drug: Morphine

Hydromorphone

EXPERIMENTAL

single dose of intravenous (IV) hydromorphone, 0.015 mg/kg intervention: 0.015 mg/kg IV hydromorphone

Drug: Hydromorphone

Interventions

MorphineDRUG

0.1 mg/kg IV morphine

Morphine
HydromorphoneDRUG

0.015 mg/kg IV hydromorphone

Also known as: Dilaudid
Hydromorphone

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults between the ages of 21 and 65 who presented to the ED with acute pain (defined as pain less than 7 days in duration) (23) of sufficient severity in the judgment of the ED attending to warrant use of IV opioids.

You may not qualify if:

  • previous allergy to morphine or hydromorphone
  • systolic blood pressure less than 90 mmHg
  • alcohol intoxication as judged by the attending physician
  • use of other opioids within the past 7 days
  • use of an Monoamine Oxidase (MAO) inhibitor
  • chronic pain syndromes (such as sickle cell disease or fibromyalgia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

PainEmergencies

Interventions

MorphineHydromorphone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Andrew K Chang, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

October 1, 2004

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

US(1)