Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

"Does a 1 Plus 1 Hydromorphone Pain Protocol Have a Similar Rate of Respiratory Depression to Physician Discretion Protocol in a Geriatric Population With Moderate to Severe Pain?"

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Respiratory Depression
• Intervention / Treatment: Drug: Hydromorphone; Drug: Usual care group

Detailed Description

This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of long bone fractures 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 screened and randomized to one of two study arms, "1+1" versus usual care group. Neither the research associate, nurse, or attending physician will be blinded to the patients randomization. Patient pain score will be assessed at baseline using VAS score. "1+1" patients will receive 1mg hydromorphone at "timepoint 0" (baseline) followed by another 1mg after 15 minutes (along with repeat VAS pain score) if the patient answers "yes" to "Do you need more pain medicine?" At 60 minutes, patient pain will be assessed a final time and if patient needs more pain medicine, additional treatment will be dictated by physician discretion. Usual care group patients will also have VAS pain scores assessed at timepoint 0, 15 and 60 minutes and will have pain treated per the discretion of the attending physician. Patients will be placed on capnometer for continuous monitoring of respiratory status to guard against any opioid induced respiratory depression. 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. We propose that the "1+1" hydromorphone protocol is easy to implement, as it includes a set timeline, a standard question, and a set dosage of a potent analgesic. We hypothesize that it will provide adequate analgesia in the majority of patients without causing the anticipated level of respiratory depression.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. Able to provide consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1mg + 1mg Hydromorphone; 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; 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.; Other Names: Dilaudid
Active Comparator: Usual Care Group; 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; 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.; Other Names: Dilaudid; Morphine; Other IV opioid medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Treatment of Patient Pain	Defined as: Declining additional pain medication at 15 minutes or requesting additional pain medication at 15 min, but declining at 60 minutes	15 min and 60 min after baseline
Change in VAS Score	A 13 mm change or greater on a VAS score	15 min and 60 min after baseline
Hypoxia	Defined as SpO2 of 93% or less for 15 seconds	From administration of drug (time 0 minutes) to end of study (60 minute mark)
Hypotension	Hypotension defined as systolic blood pressure less than 90 mmHg	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)
Serious Adverse Events	Defined as prolonged hypoxia, need for positive pressure ventilation or intubation, hospital admission secondary to study drug.	From administration of drug (time 0 minutes) to end of study (60 minute mark)

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Actual): April 16, 2014
• Study Completion (Actual): April 16, 2014

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 6, 2013

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Opioids; Hydromorphone; regimen
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Respiratory Tract Diseases; Mood Disorders; Respiration Disorders; Depression; Depressive Disorder; Respiratory Insufficiency; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Hydromorphone
• Other Study ID Numbers: HN - 4325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No