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Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

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ClinicalTrials.gov Identifier: NCT01784991
Recruitment Status : Terminated (difficulty in recruiting)
First Posted : February 6, 2013
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Kenneth Deitch, Albert Einstein Healthcare Network

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 Not Applicable

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  (Clinical Trial)
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?"
Study Start Date : December 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Respiratory Depression [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 15 min and 60 min after baseline ]
    A 13 mm change or greater on a VAS score

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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784991


Locations
United States, Pennsylvania
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

Responsible Party: Kenneth Deitch, Research Director, Dept. of Emergency Medicine, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01784991     History of Changes
Other Study ID Numbers: (H)N - 4325
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by Kenneth Deitch, Albert Einstein Healthcare Network:
Pain
Opioids
Hydromorphone
regimen

Additional relevant MeSH terms:
Depression
Depressive Disorder
Respiratory Insufficiency
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents