Clinical trial NCT01784991: Study of Respiratory Depression When Using a Hydromorphone Pain Protocol
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Respiratory Depression
Keywords: Pain
Opioids
Hydromorphone
regimen
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 116
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Respiratory Depression
timeFrame: From administration of drug (time 0 minutes) to end of study (60 minute mark)
Secondary outcomes:
measure: Successful Treatment of Patient Pain
timeFrame: 15 min and 60 min after baseline
measure: Change in VAS Score
timeFrame: 15 min and 60 min after baseline
measure: Hypoxia
timeFrame: From administration of drug (time 0 minutes) to end of study (60 minute mark)
measure: Hypotension
timeFrame: Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)
measure: Allergic Reaction to Study Drug
timeFrame: From administration of drug (time 0 minutes) to end of study (60 minute mark)
measure: Serious Adverse Events
timeFrame: From administration of drug (time 0 minutes) to end of study (60 minute mark)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Medical Center
name: Kenneth Deitch, DO
role: PRINCIPAL_INVESTIGATOR
References: