Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

• Sponsor: Albert Einstein Healthcare Network (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01784991
• Collaborator: (none)
• Enrollment: 116
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.5
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Respiratory Depression	Drug: Hydromorphone; Drug: Usual care group	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: "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?"
• Actual Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Apr 16, 2014
• Actual Study Completion Date: Apr 16, 2014

Arms and Interventions

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: Morphine Dilaudid Other IV opioid medications

Outcome Measures

Primary Outcome Measures

1. Respiratory Depression [From administration of drug (time 0 minutes) to end of study (60 minute mark)]

   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)

Secondary Outcome Measures

1. Successful Treatment of Patient Pain [15 min and 60 min after baseline]

   Defined as: Declining additional pain medication at 15 minutes or requesting additional pain medication at 15 min, but declining at 60 minutes

2. Change in VAS Score [15 min and 60 min after baseline]

   A 13 mm change or greater on a VAS score

3. Hypoxia [From administration of drug (time 0 minutes) to end of study (60 minute mark)]

   Defined as SpO2 of 93% or less for 15 seconds

4. Hypotension [Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)]

   Hypotension defined as systolic blood pressure less than 90 mmHg

5. Allergic Reaction to Study Drug [From administration of drug (time 0 minutes) to end of study (60 minute mark)]

6. Serious Adverse Events [From administration of drug (time 0 minutes) to end of study (60 minute mark)]

   Defined as prolonged hypoxia, need for positive pressure ventilation or intubation, hospital admission secondary to study drug.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141

Sponsors and Collaborators

• Albert Einstein Healthcare Network

Investigators

• Principal Investigator: Kenneth Deitch, DO, Albert Einstein Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Albert Einstein Healthcare Network
• ClinicalTrials.gov Identifier: NCT01784991
• Other Study ID Numbers: HN - 4325
• First Posted: Feb 6, 2013
• Last Update Posted: Mar 19, 2020
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Albert Einstein Healthcare Network: Pain; Opioids; Hydromorphone; regimen
• Additional relevant MeSH terms: Respiratory Insufficiency; Depression; Depressive Disorder; Morphine; Hydromorphone

Study Results

Participant Flow

Recruitment Details	0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Pre-assignment Detail	0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Arm/Group Title	1mg + 1mg Hydromorphone	Usual Care Group
Arm/Group Description	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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.	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. 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.
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	1mg + 1mg Hydromorphone	Usual Care Group	Total
Arm/Group Description	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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.	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. 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.	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Respiratory Depression
Description	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)
Time Frame	From administration of drug (time 0 minutes) to end of study (60 minute mark)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	1mg + 1mg Hydromorphone	Usual Care Group
Arm/Group Description	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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.	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. 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.
Measure Participants	0	0

2. Secondary Outcome

Title	Successful Treatment of Patient Pain
Description	Defined as: Declining additional pain medication at 15 minutes or requesting additional pain medication at 15 min, but declining at 60 minutes
Time Frame	15 min and 60 min after baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	1mg + 1mg Hydromorphone	Usual Care Group
Arm/Group Description	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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.	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. 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.
Measure Participants	0	0

3. Secondary Outcome

Title	Change in VAS Score
Description	A 13 mm change or greater on a VAS score
Time Frame	15 min and 60 min after baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	1mg + 1mg Hydromorphone	Usual Care Group
Arm/Group Description	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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.	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. 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.
Measure Participants	0	0

4. Secondary Outcome

Title	Hypoxia
Description	Defined as SpO2 of 93% or less for 15 seconds
Time Frame	From administration of drug (time 0 minutes) to end of study (60 minute mark)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	1mg + 1mg Hydromorphone	Usual Care Group
Arm/Group Description	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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.	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. 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.
Measure Participants	0	0

5. Secondary Outcome

Title	Hypotension
Description	Hypotension defined as systolic blood pressure less than 90 mmHg
Time Frame	Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	1mg + 1mg Hydromorphone	Usual Care Group
Arm/Group Description	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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.	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. 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.
Measure Participants	0	0

6. Secondary Outcome

Title	Allergic Reaction to Study Drug
Time Frame	From administration of drug (time 0 minutes) to end of study (60 minute mark)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	1mg + 1mg Hydromorphone	Usual Care Group
Arm/Group Description	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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.	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. 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.
Measure Participants	0	0

7. Secondary Outcome

Title	Serious Adverse Events
Description	Defined as prolonged hypoxia, need for positive pressure ventilation or intubation, hospital admission secondary to study drug.
Time Frame	From administration of drug (time 0 minutes) to end of study (60 minute mark)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	1mg + 1mg Hydromorphone	Usual Care Group
Arm/Group Description	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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.	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. 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.
Measure Participants	0	0

Adverse Events

Time Frame	0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Adverse Event Reporting Description	0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Arm/Group Title	1mg + 1mg Hydromorphone		Usual Care Group
Arm/Group Description	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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.		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. 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.
All Cause Mortality
	1mg + 1mg Hydromorphone		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	1mg + 1mg Hydromorphone		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	1mg + 1mg Hydromorphone		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.