NCT00305110

Brief Summary

The purpose of this study is to determine the safety and speed of onset of 2mg intravenous hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency department with acute severe pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
298

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

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

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
11.9 years until next milestone

Results Posted

Study results publicly available

August 20, 2018

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

March 17, 2006

Results QC Date

February 22, 2018

Last Update Submit

August 13, 2018

Conditions

Acute Pain

Keywords

PainAcuteEmergency DepartmentSevereHydromorphoneDilaudidAdult

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Requiring Naloxone

    Naloxone is a reversal agent - a medication that reverses the effects of another. Hydromorphone is an opiate pain medication that acts as a depressant to the body, thereby slowing it down. A large slow down is dangerous, as it can cause the breathing rate to slow down too much and prevent enough oxygen from entering the body and reaching the brain, resulting in death. Naloxone is a medication that blocks the receptors binding opiate pain medication and reversing the body's reaction to the hydromorphone, allowing body processes to return to normal speeds, including the breathing rate. The use of naloxone in the study indicates that the participant received too much pain medication or reacted more strongly than the average person, requiring the rescue medication to reverse the negative effects. The number of participants who required naloxone is assessed.

    immediately after infusion, up to 120 minutes post infusion

Secondary Outcomes (4)

  • Number of Participants Experiencing a Respiratory Rate Lower Than 12 Breaths Per Minute

    immediately after infusion, up to 120 minutes post infusion

  • Number of Participants Experiencing a Systolic Blood Pressure Less Than 90 mmHg

    Immediately after infusion, up to 120 minutes post infusion

  • Oxygen Desaturation Measured Over 2-hour Time Frame

    immediately after infusion, up to 120 minutes post infusion

  • Oxygen Saturation Measured Over 2-hour Time Frame

    baseline to 120 minutes post infusion

Study Arms (1)

2 mg IV hydromorphone

EXPERIMENTAL

2 mg IV hydromorphone administered over 2-3 minutes

Drug: 2 mg IV hydromorphone

Interventions

2 mg IV hydromorphoneDRUG
Also known as: Dilaudid
2 mg IV hydromorphone

Eligibility Criteria

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

You may qualify if:

  • Age greater than 21 years
  • Age less than 65 years of age
  • Pain with onset within 7 days
  • ED attending physician's judgment that patient's pain warrants use of morphine
  • Normal mental status

You may not qualify if:

  • Prior use of methadone
  • Use of other opioids or tramadol within past seven days
  • Prior adverse reaction to hydromorphone.
  • Chronic pain syndrome
  • Alcohol intoxication
  • SBP \<90 mm Hg
  • Use of MAO inhibitors in past 30 days
  • C02 measurement greater than 46

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

Acute PainPainEmergenciesLymphoma, Follicular

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Andrew Chang, MD, MS
Organization
Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center
achang@montefiore.org
718-920-7476

Study Officials

  • Andrew K Chang, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 17, 2006

First Posted

March 21, 2006

Study Start

January 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

August 20, 2018

Results First Posted

August 20, 2018

Record last verified: 2018-08

Locations

US(1)