Study of Respiratory Depression When Using a Hydromorphone Pain Protocol

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?

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01784991

Enrollment

116

Registered

2013-02-06

Start date

2011-12-31

Completion date

2014-04-16

Last updated

2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Respiratory Depression

Keywords

Pain, Opioids, Hydromorphone, regimen

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.

Interventions

DRUGHydromorphone

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

DRUGUsual 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Change in VAS Score	15 min and 60 min after baseline	A 13 mm change or greater on a VAS score
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
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.
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

Countries

United States

Participant flow

Recruitment details

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Pre-assignment details

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Participants by arm

Arm	Count
1mg + 1mg 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. Hydromorphone: 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.	0
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. 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.	0
Total	0

Baseline characteristics

Characteristic	—
Region of Enrollment United States	— participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

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)

Time frame: From administration of drug (time 0 minutes) to end of study (60 minute mark)