Study of Respiratory Depression When Using a Hydromorphone Pain Protocol
Stopped early · Not applicable
Conditions studied: Pain, Respiratory Depression
In brief
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.
Key facts
- Study ID
- NCT01784991
- Run by
- Albert Einstein Healthcare Network
- People needed
- 116
- Starts
- 2011-12-01
- Expected to finish
- 2014-04-16
- Last updated by the study team
- 2020-03-19
Who can join
Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Able to provide consent.
You may not qualify if…
- Patient or family member unable to consent
- Altered mental status
- SpO2 less than 95 percent
- Allergy to opiates
- Hypotension (Systolic blood pressure less than 90 mmHg)
- Chronic oxygen dependency or known CO2 retention
- Acute ETOH or drug intoxication
- History of chronic pain syndrome or chronic use of opiate narcotics
- History of opiate/heroin addiction, past or current.
- End stage renal disease/dialysis patient
- Chronic metabolic acidosis
- Physician feels that patient would be poor candidate for study
- Weight less than 100 pounds, all patients will be weighted
- Patients younger than 60 years of age
Where it is running
- Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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