Trial Outcomes & Findings for Study of Respiratory Depression When Using a Hydromorphone Pain Protocol (NCT NCT01784991)
NCT ID: NCT01784991
Last Updated: 2020-03-19
Results Overview
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)
TERMINATED
NA
116 participants
From administration of drug (time 0 minutes) to end of study (60 minute mark)
2020-03-19
Participant Flow
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
Participant milestones
| Measure |
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.
|
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.
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Respiratory Depression When Using a Hydromorphone Pain Protocol
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: From administration of drug (time 0 minutes) to end of study (60 minute mark)Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 min and 60 min after baselinePopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Defined as: Declining additional pain medication at 15 minutes or requesting additional pain medication at 15 min, but declining at 60 minutes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 min and 60 min after baselinePopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
A 13 mm change or greater on a VAS score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From administration of drug (time 0 minutes) to end of study (60 minute mark)Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Defined as SpO2 of 93% or less for 15 seconds
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Hypotension defined as systolic blood pressure less than 90 mmHg
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From administration of drug (time 0 minutes) to end of study (60 minute mark)Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From administration of drug (time 0 minutes) to end of study (60 minute mark)Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Defined as prolonged hypoxia, need for positive pressure ventilation or intubation, hospital admission secondary to study drug.
Outcome measures
Outcome data not reported
Adverse Events
1mg + 1mg Hydromorphone
Usual Care Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kamran Mohiuddin, Director Clinical Research Emergency Department
Albert Einstein Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place