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Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

NCT01784991 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2020-03-19

Study results available
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Summary

This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of moderate to sever pain in the Emergency Department. Appropriate patients 60 years and older who present with a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia will be enrolled in one of two study arms, "1+1" versus usual care group. 1+1 patients will receive 1mg hydromorphone followed by another 1mg after 15 minutes if pain persists. Usual care group patients will have pain treated per the discretion of the attending physician. Respiratory status, vital signs, and pain scores will be monitor to assess the efficiency of pain control as well as the safety of pain medicine administration in terms of respiratory depression.

Conditions

  • Pain
  • Respiratory Depression

Interventions

DRUG

Hydromorphone

1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.

DRUG

Usual care group

Patient will have pain treated at timepoint 0 as per usual care based on physician discretion. At 15 min timepoint, patients will be asked for pain level, and then subsequently treated as per physician discretion.

Sponsors & Collaborators

  • Albert Einstein Healthcare Network

    lead OTHER

Principal Investigators

  • Kenneth Deitch, DO · Albert Einstein Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-04-16
Completion
2014-04-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01784991 on ClinicalTrials.gov