Trial Outcomes & Findings for Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients (NCT NCT00682435)

NCT ID: NCT00682435

Last Updated: 2018-08-13

Results Overview

Adequate analgesia is defined as declining additional hydromorphone within 1 hour of entering the protocol

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 230 participants
• Primary outcome timeframe: 60 minutes after medication infused
• Results posted on: 2018-08-13

Participant Flow

Participant milestones

Measure	Hydromorphone 1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Overall Study STARTED	230
Overall Study Ensured Enrolled Only Once	228
Overall Study Sufficient Data to Carry Out Analysis	223
Overall Study COMPLETED	223
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Hydromorphone 1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Overall Study Insufficient data	5
Overall Study Erroneously enrolled twice	2

Baseline Characteristics

Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients

Baseline characteristics by cohort

Measure	Hydromorphone n=223 Participants 1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Age, Continuous	40 years n=5 Participants
Sex: Female, Male Female	144 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	134 Participants n=5 Participants
Race/Ethnicity, Customized Black	65 Participants n=5 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants
Race/Ethnicity, Customized Other	9 Participants n=5 Participants
Region of Enrollment United States	223 Participants n=5 Participants
Weight	179 lbs n=5 Participants
Location of pain Abdomen	149 Participants n=5 Participants
Location of pain Other	74 Participants n=5 Participants
Pain intensity 4-6	12 Participants n=5 Participants
Pain intensity 7	17 Participants n=5 Participants
Pain intensity 8	39 Participants n=5 Participants
Pain intensity 9	36 Participants n=5 Participants
Pain intensity 10	119 Participants n=5 Participants
Number of participants experiencing Nausea or Vomiting before baseline Yes	85 Participants n=5 Participants
Number of participants experiencing Nausea or Vomiting before baseline No	138 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes after medication infused

Population: Those given a second dose only included patients who wanted more pain medication 15 minutes after 1st dose. 7 patients did not receive the second dose, resulting in 44 patients analyzed instead of expected 51

Adequate analgesia is defined as declining additional hydromorphone within 1 hour of entering the protocol

Outcome measures

Measure	Hydromorphone n=223 Participants 1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Number of Patients Who Had Adequate Analgesia 15 minutes after 1st 1mg dose of IV hydromorphone · wanted more pain medication	51 Participants
Number of Patients Who Had Adequate Analgesia 15 minutes after 1st 1mg dose of IV hydromorphone · Did not want more pain medication	172 Participants
Number of Patients Who Had Adequate Analgesia 15 minutes after 2nd 1 mg dose of IV hydromorphone · wanted more pain medication	9 Participants
Number of Patients Who Had Adequate Analgesia 15 minutes after 2nd 1 mg dose of IV hydromorphone · Did not want more pain medication	35 Participants

PRIMARY outcome

Timeframe: 120 minutes after medication infused

Population: Total of 223 split into patients who received only 1 mg of IV hydromorphone (179) and those who received 2 mg of IV hydromorphone

primary safety outcome, defined as number of participants who experienced oxygen saturation < 95%

Outcome measures

Measure	Hydromorphone n=223 Participants 1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Number of Patients With Oxygen Desaturation Less Than 95% 1 mg IV hydromorphone	11 Participants
Number of Patients With Oxygen Desaturation Less Than 95% 2 mg IV hydromorphone	0 Participants

SECONDARY outcome

Timeframe: 60 minutes after medication infused

Pain intensity is measured on the numerical rating scale (NRS), with a pain score from 0 (no pain) to 10 (worst pain imaginable). The reduction in pain intensity is defined here as a change in pain score by 2 or more units.

Outcome measures

Measure	Hydromorphone n=223 Participants 1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Number of Patients With Reduction in Pain Intensity	86 % of participants

SECONDARY outcome

Timeframe: 60 minutes after medication infused

Pain intensity is measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable) from baseline to 60 minutes after medication infused

Outcome measures

Measure	Hydromorphone n=223 Participants 1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Change in Pain Intensity	6 units on a scale Interval 4.0 to 8.0

Adverse Events

1 mg Hydromorphone

Serious events: 0 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	1 mg Hydromorphone n=223 participants at risk 1 mg IV hydromorphone, + optional 1 mg IV hydromorphone 15 minutes later Hydromorphone: 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Respiratory, thoracic and mediastinal disorders Oxygen saturation < 95%	4.9% 11/223 • 60 minutes
Cardiac disorders Pulse rate < 60 beats/min	9.6% 21/219 • 60 minutes
Vascular disorders Systolic blood pressure < 100 mmHg	0.90% 2/223 • 60 minutes
Respiratory, thoracic and mediastinal disorders Respiratory rate < 12 breaths/min	1.3% 3/223 • 60 minutes
Gastrointestinal disorders Nausea	18.1% 25/138 • 60 minutes
Gastrointestinal disorders Vomiting	6.5% 9/138 • 60 minutes
Skin and subcutaneous tissue disorders Pruritus	5.4% 12/223 • 60 minutes

Additional Information

Andrew Chang, MD, MS

Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center

Phone: 718-920-7464

Email: achang@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place