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Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

Information source: Albert Einstein Healthcare Network
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Respiratory Depression

Intervention: Hydromorphone (Drug); Usual care group (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Albert Einstein Healthcare Network

Official(s) and/or principal investigator(s):
Kenneth Deitch, DO, Principal Investigator, Affiliation: Albert Einstein Medical Center

Overall contact:
Kathia Damiron, MD, Phone: 215-456-2313

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.

Clinical Details

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?"

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Respiratory Depression

Secondary outcome:

Successful treatment of patient pain

Change in VAS score

Hypoxia

Hypotension

Allergic reaction to study drug

Serious Adverse Events

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.

Eligibility

Minimum age: 60 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

Kathia Damiron, MD, Phone: 215-456-2313

Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States; Recruiting
Michael Kowalski, DO, Sub-Investigator
Matthew Salzman, MD, Sub-Investigator
Kathia Damiron, MD, Sub-Investigator
Carl Chudnofsky, MD, Sub-Investigator
Additional Information

Starting date: December 2011
Last updated: February 5, 2013

Page last updated: February 07, 2013

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