Trial Outcomes & Findings for Safety and Efficacy of Intravenous Hydromorphone in Elderly Emergency Department Patients With Acute Severe Pain (NCT NCT01429285)

Last Updated: 2018-05-18

Results Overview

Number of patients with "successful treatment" is defined as the number of patients who declined additional pain medication within 1 hour of study entry when asked the question, "Do you want more pain medication?". This measure looks at declining pain medication at either 15 minutes or 60 minutes, whereas 4. Post-Hoc refers only to the answer to the question at the 60 minute mark post-baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

350 participants

Primary outcome timeframe

1 hour

Results posted on

2018-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Hydromorphone Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose	Usual Care Usual care Usual care: Attending administers any IV opioid in any dose he chooses
Overall Study STARTED	175	175
Overall Study Given IV Opioids	166	171
Overall Study Completed Primary Outcome Data	161	168
Overall Study Confirmation of no Duplicate Enrollment	153	166
Overall Study COMPLETED	153	166
Overall Study NOT COMPLETED	22	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydromorphone Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose	Usual Care Usual care Usual care: Attending administers any IV opioid in any dose he chooses
Overall Study Protocol Violation	9	4
Overall Study Missing Data	5	3
Overall Study Erroneously Enrolled Twice	8	2

Baseline Characteristics

Safety and Efficacy of Intravenous Hydromorphone in Elderly Emergency Department Patients With Acute Severe Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydromorphone n=153 Participants Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose	Usual Care n=166 Participants Usual care Usual care: Attending administers any IV opioid in any dose he chooses	Total n=319 Participants Total of all reporting groups
Age, Continuous	75 years STANDARD_DEVIATION 7 • n=5 Participants	74 years STANDARD_DEVIATION 6 • n=7 Participants	74 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	108 Participants n=7 Participants	213 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	58 Participants n=7 Participants	106 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	97 Participants n=5 Participants	103 Participants n=7 Participants	200 Participants n=5 Participants
Race/Ethnicity, Customized African American	35 Participants n=5 Participants	44 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	153 Participants n=5 Participants	166 Participants n=7 Participants	319 Participants n=5 Participants
Weight	162 lbs STANDARD_DEVIATION 33 • n=5 Participants	165 lbs STANDARD_DEVIATION 38 • n=7 Participants	164 lbs STANDARD_DEVIATION 36 • n=5 Participants
Diagnosis Non-specific abdominal pain	50 Participants n=5 Participants	57 Participants n=7 Participants	107 Participants n=5 Participants
Diagnosis Musculoskeletal pain	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Diagnosis Back pain	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Diagnosis Colitis/diverticulitis	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Diagnosis Small Bowel Obstruction	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Diagnosis Extremity fracture	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Diagnosis biliary colic/cholecystitis	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Diagnosis Kidney stone/pyelonephritis	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Diagnosis Appendicitis	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Diagnosis Other (pancreatitis, perforated viscus, etc)	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Pain Intensity NRS = 3-6	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Pain Intensity NRS = 7	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Pain Intensity NRS = 8	31 Participants n=5 Participants	28 Participants n=7 Participants	59 Participants n=5 Participants
Pain Intensity NRS = 9	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Pain Intensity NRS = 10	76 Participants n=5 Participants	81 Participants n=7 Participants	157 Participants n=5 Participants
Nauseated or vomited before receiving opioids in the ED Yes	65 Participants n=5 Participants	77 Participants n=7 Participants	142 Participants n=5 Participants
Nauseated or vomited before receiving opioids in the ED No	87 Participants n=5 Participants	89 Participants n=7 Participants	176 Participants n=5 Participants
Nauseated or vomited before receiving opioids in the ED Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)

Outcome measures

Outcome measures
Measure	Hydromorphone n=153 Participants Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose	Usual Care n=166 Participants Usual care Usual care: Attending administers any IV opioid in any dose he chooses
Number of Patients With Successful Treatment Achieved satisfactory analgesia within 60 min	127 Participants	137 Participants
Number of Patients With Successful Treatment No satisfactory analgesia within 60 min	26 Participants	29 Participants

SECONDARY outcome

Timeframe: 60 minutes

Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable"). The change in scores over time is calculated by subtracting the score at 60 minutes from the score at baseline (before treatment). These change values were then averaged.

Outcome measures

Outcome measures
Measure	Hydromorphone n=153 Participants Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose	Usual Care n=166 Participants Usual care Usual care: Attending administers any IV opioid in any dose he chooses
Mean Change in Pain Intensity From Baseline to 60 Minutes	5.4 units on a scale Standard Deviation 2.9	5.2 units on a scale Standard Deviation 3.1

POST_HOC outcome

Timeframe: 15 minutes

Satisfactory Analgesia is defined as declining additional pain medication when asked the question, "Do you want more pain medication?"

Outcome measures

Outcome measures
Measure	Hydromorphone n=153 Participants Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose	Usual Care n=166 Participants Usual care Usual care: Attending administers any IV opioid in any dose he chooses
Number of Patients Who Achieved Satisfactory Analgesia at 15 Minutes Post-baseline	89 Participants	111 Participants

POST_HOC outcome

Timeframe: 60 minutes

"Satisfactory analgesia" is defined as the patient declining additional pain medication when asked the question, "Do you want more pain medication?". This measure refers only to the answer to this question asked at the 60 minute mark. The Primary Outcome (1. Primary Outcome - Number of Patients with successful treatment) refers to the answering "no" to this question at 15 minutes or 60 minutes post-baseline.

Outcome measures

Outcome measures
Measure	Hydromorphone n=153 Participants Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose	Usual Care n=166 Participants Usual care Usual care: Attending administers any IV opioid in any dose he chooses
Number of Patients Who Achieved Satisfactory Analgesia at 60 Minutes Post-baseline	111 Participants	119 Participants

POST_HOC outcome

Timeframe: 60 minutes

Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable"). The 50% or greater change in pain score is measured by subtracting the pain score at 60 minutes from the pain score at baseline, then dividing that value by the original baseline value and multiplying by 100% to get a percent change value.

Outcome measures

Outcome measures
Measure	Hydromorphone n=153 Participants Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose	Usual Care n=166 Participants Usual care Usual care: Attending administers any IV opioid in any dose he chooses
Number of Patients With 50% or Greater Decline in Pain Intensity Score From Baseline to 60 Minutes	106 Participants	107 Participants

POST_HOC outcome

Timeframe: 60 minutes

Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable").

Outcome measures

Outcome measures
Measure	Hydromorphone n=153 Participants Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose	Usual Care n=166 Participants Usual care Usual care: Attending administers any IV opioid in any dose he chooses
Number of Patients With a Pain Intensity Score of 3 or Less at 60 Minutes	83 Participants	87 Participants

POST_HOC outcome

Timeframe: 60 minutes

Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable").

Outcome measures

Outcome measures
Measure	Hydromorphone n=153 Participants Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose	Usual Care n=166 Participants Usual care Usual care: Attending administers any IV opioid in any dose he chooses
Pain Intensity Score at 60 Minutes	3 units on a scale Interval 0.0 to 5.0	3 units on a scale Interval 0.0 to 6.0

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Hydromorphone

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Usual Care n=166 participants at risk Usual care Usual care: Attending administers any IV opioid in any dose he chooses	Hydromorphone n=153 participants at risk Hydromorphone protocol Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
Respiratory, thoracic and mediastinal disorders Oxygen saturation <95%	7.8% 13/166 • 60 minutes The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)	4.6% 7/153 • 60 minutes The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
Vascular disorders Systolic blood pressure <90 mmHg	1.2% 2/166 • 60 minutes The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)	2.6% 4/153 • 60 minutes The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
Skin and subcutaneous tissue disorders Pruritus	4.8% 8/166 • 60 minutes The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)	1.3% 2/153 • 60 minutes The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
Gastrointestinal disorders Nausea	6.7% 6/89 • 60 minutes The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)	11.5% 10/87 • 60 minutes The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
Gastrointestinal disorders Vomiting	3.4% 3/89 • 60 minutes The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)	4.6% 4/87 • 60 minutes The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)

Additional Information

Andrew Chang, MD, MS

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

Phone: 718-920-7464

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place