Not provided
Not provided
Not provided
Not provided
Not provided
difficulty in recruiting
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1mg + 1mg Hydromorphone | Active Comparator | 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. |
|
| Usual Care Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | 1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in VAS Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Deitch, DO | Albert Einstein Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | Posted | From administration of drug (time 0 minutes) to end of study (60 minute mark) |
|
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kamran Mohiuddin, Director Clinical Research Emergency Department | Albert Einstein Medical Center | 2154562313 | MOHIUDDK@EINSTEIN.EDU |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual care group | Drug | 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. |
|
|
A 13 mm change or greater on a VAS score
| 15 min and 60 min after baseline |
| 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) |
| 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) |
| Allergic Reaction to Study Drug | From administration of drug (time 0 minutes) to end of study (60 minute mark) |
| 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) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| OG001 | 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. |
|
| 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 | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | Posted | 15 min and 60 min after baseline |
|
|
| Secondary | Change in VAS Score | A 13 mm change or greater on a VAS score | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | Posted | 15 min and 60 min after baseline |
|
|
| Secondary | Hypoxia | Defined as SpO2 of 93% or less for 15 seconds | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | Posted | 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 | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | Posted | Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark) |
|
|
| Secondary | Allergic Reaction to Study Drug | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | Posted | 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. | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | Posted | From administration of drug (time 0 minutes) to end of study (60 minute mark) |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D012140 | Respiratory Tract Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |