Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

Not Applicable

Terminated

Conditions: Pain
Respiratory Depression

Interventions: Drug: Usual care group
Drug: Hydromorphone

Registration Number: NCT01784991

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 116

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Group	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.
1mg + 1mg Hydromorphone	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.

Primary Outcome Measures

Name	Time	Method
Respiratory Depression	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

Name	Time	Method
Hypoxia	From administration of drug (time 0 minutes) to end of study (60 minute mark)	Defined as SpO2 of 93% or less for 15 seconds
Successful Treatment of Patient Pain	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
Change in VAS Score	15 min and 60 min after baseline	A 13 mm change or greater on a VAS score
Hypotension	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
Allergic Reaction to Study Drug	From administration of drug (time 0 minutes) to end of study (60 minute mark)
Serious Adverse Events	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.