Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

Pain Clinical Trial

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?"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01784991
• Other study ID #: HN - 4325
• Status: Terminated
• Phase: N/A
• Start date: December 2011
• Est. completion date: April 16, 2014

Study information

• Verified date: December 2016
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: April 16, 2014
• Est. primary completion date: April 16, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Pain
• Respiratory Depression
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Depression	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)	From administration of drug (time 0 minutes) to end of study (60 minute mark)
Secondary	Successful Treatment of Patient Pain	Defined as: Declining additional pain medication at 15 minutes or requesting additional pain medication at 15 min, but declining at 60 minutes	15 min and 60 min after baseline
Secondary	Change in VAS Score	A 13 mm change or greater on a VAS score	15 min and 60 min after baseline
Secondary	Hypoxia	Defined as SpO2 of 93% or less for 15 seconds	From administration of drug (time 0 minutes) to end of study (60 minute mark)
Secondary	Hypotension	Hypotension defined as systolic blood pressure less than 90 mmHg	Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)
Secondary	Allergic Reaction to Study Drug		From administration of drug (time 0 minutes) to end of study (60 minute mark)
Secondary	Serious Adverse Events	Defined as prolonged hypoxia, need for positive pressure ventilation or intubation, hospital admission secondary to study drug.	From administration of drug (time 0 minutes) to end of study (60 minute mark)