Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

NCT01784991 | Terminated Results DMC

• 1 other identifier: HN - 4325
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pain; Opioids; Hydromorphone; regimen

Outcome Measures

Primary Outcomes (1)

• Respiratory Depression

  Incidence of respiratory depression (defined as a ETCO2 of 50 mmHg or greater, a 10% change from baseline, or loss of waveform for 15 seconds or greater)

  From administration of drug (time 0 minutes) to end of study (60 minute mark)

Secondary Outcomes (6)

• Successful Treatment of Patient Pain

  15 min and 60 min after baseline

• Change in VAS Score

  15 min and 60 min after baseline

• Hypoxia

  From administration of drug (time 0 minutes) to end of study (60 minute mark)

• Hypotension

  Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)

• Allergic Reaction to Study Drug

  From administration of drug (time 0 minutes) to end of study (60 minute mark)

Study Arms (2)

1mg + 1mg Hydromorphone

ACTIVE COMPARATOR

Patient will receive 1 mg of hydromorphone for pain at timepoint 0. After 15 minutes, patients will be asked if the still need pain medication. If yes, patients will immediately receive 1mg hydromorphone. Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.

Drug: Hydromorphone

Usual Care Group

ACTIVE COMPARATOR

Patient will receive pain medicine per doctor's discretion at timepoint 0. After 15 minutes, patients will be asked if they still need pain medication. If yes, physicians will not be notified and patient will continue to have pain managed as deemed necessary by physician per "usual care." Patients will be under continuous monitoring for respiratory depression via capnometer. At 60 minutes, pain will be re-assessed for a second time. If needed, physician will give additional pain meds per their discretion.

Drug: Usual care group

Interventions

Hydromorphone DRUG

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

Also known as: Dilaudid

1mg + 1mg Hydromorphone

Usual care group DRUG

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.

Also known as: Morphine, Dilaudid, Other IV opioid medications

Usual Care Group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient who presents 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
• Able to provide consent.

You may not qualify if:

• Patient or family member unable to consent
• Altered mental status
• SpO2 less than 95 percent
• Allergy to opiates
• Hypotension (Systolic blood pressure less than 90 mmHg)
• Chronic oxygen dependency or known CO2 retention
• Acute ETOH or drug intoxication
• History of chronic pain syndrome or chronic use of opiate narcotics
• History of opiate/heroin addiction, past or current.
• End stage renal disease/dialysis patient
• Chronic metabolic acidosis
• Physician feels that patient would be poor candidate for study
• Weight less than 100 pounds, all patients will be weighted
• Patients younger than 60 years of age

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Pain; Respiratory Insufficiency

Interventions

Hydromorphone; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Results Point of Contact

• Title: Kamran Mohiuddin, Director Clinical Research Emergency Department
• Organization: Albert Einstein Medical Center

MOHIUDDK@EINSTEIN.EDU

2154562313

Study Officials

• Kenneth Deitch, DO

  Albert Einstein Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: February 6, 2013
• Study Start: December 1, 2011
• Primary Completion: April 16, 2014
• Study Completion: April 16, 2014
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)