Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

NCT ID: NCT01784991

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-04-16

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.

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.

Conditions

Pain; Respiratory Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Hydromorphone

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Usual care group

Intervention Type: 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.

Interventions

Hydromorphone

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Dilaudid; Morphine; Dilaudid; Other IV opioid medications

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Deitch, DO

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Medical Center

Locations

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

HN - 4325

Identifier Type: -

Identifier Source: org_study_id