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Pain | Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Respiratory Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Hydromorphone1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.

Drug:Usual care groupPatient 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1mg + 1mg HydromorphonePatient 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.

Usual Care GroupPatient 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.

Study Status

Terminated

Start Date: December 2011

Completed Date: April 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Respiratory Depression

Secondary Outcome: Successful treatment of patient pain

Study sponsors, principal investigator, and references

Principal Investigator: Kenneth Deitch, DO

Lead Sponsor: Albert Einstein Healthcare Network

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01784991

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