Trial Outcomes & Findings for Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone (NCT NCT01311895)

Last Updated: 2018-05-18

Results Overview

The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

350 participants

Primary outcome timeframe

60 minutes

Results posted on

2018-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	H2O (2 mg IV Hydromorphone) 2 mg IV hydromorphone H2O: 2 mg intravenous (IV) hydromorphone	1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) 1 mg intravenous (IV) hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?" 1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Overall Study STARTED	175	175
Overall Study COMPLETED	175	175
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	H2O (2 mg IV Hydromorphone) n=166 Participants 2 mg IV hydromorphone H2O: 2 mg IV hydromorphone	1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) n=168 Participants 1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?" 1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"	Total n=334 Participants Total of all reporting groups
Age, Continuous	44 years n=5 Participants	42 years n=7 Participants	43 years n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	107 Participants n=7 Participants	210 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	61 Participants n=7 Participants	124 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	109 Participants n=5 Participants	116 Participants n=7 Participants	225 Participants n=5 Participants
Race/Ethnicity, Customized Black	48 Participants n=5 Participants	44 Participants n=7 Participants	92 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	166 Participants n=5 Participants	168 Participants n=7 Participants	334 Participants n=5 Participants
Weight	180 lbs n=5 Participants	186 lbs n=7 Participants	184 lbs n=5 Participants
Location of pain Abdomen	116 Participants n=5 Participants	112 Participants n=7 Participants	228 Participants n=5 Participants
Location of pain Other	50 Participants n=5 Participants	56 Participants n=7 Participants	106 Participants n=5 Participants
Pain intensity 3-7	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Pain intensity 8	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Pain intensity 9	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Pain intensity 10	98 Participants n=5 Participants	92 Participants n=7 Participants	190 Participants n=5 Participants
Nauseated or vomited before receiving opioids in the Emergency Department (ED) Yes	108 Participants n=5 Participants	105 Participants n=7 Participants	213 Participants n=5 Participants
Nauseated or vomited before receiving opioids in the Emergency Department (ED) No	58 Participants n=5 Participants	63 Participants n=7 Participants	121 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Population: The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)

Outcome measures

Outcome measures
Measure	H2O (2 mg IV Hydromorphone) n=166 Participants 2 mg IV hydromorphone administered over 2-3 minutes as initial dose H2O: 2 mg IV hydromorphone	1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) n=168 Participants 1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?" 1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Number of Patients With Satisfactory Pain Management at 60 Minutes	112 Participants	113 Participants

SECONDARY outcome

Timeframe: 60 minutes

Pain intensity is measured in numerical rating scale (NRS) units from 0 ("no pain") to 10 ("worst pain imaginable"). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department.

Outcome measures

Outcome measures
Measure	H2O (2 mg IV Hydromorphone) n=166 Participants 2 mg IV hydromorphone administered over 2-3 minutes as initial dose H2O: 2 mg IV hydromorphone	1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) n=168 Participants 1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?" 1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Mean Change in Pain Intensity From Baseline to 60 Minutes	6.1 units on a scale Standard Deviation 3.1	5.7 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 60 minutes

Outcome measures

Outcome measures
Measure	H2O (2 mg IV Hydromorphone) n=166 Participants 2 mg IV hydromorphone administered over 2-3 minutes as initial dose H2O: 2 mg IV hydromorphone	1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) n=168 Participants 1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?" 1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes	112 Participants	112 Participants

Adverse Events

H2O (2 mg IV Hydromorphone)

Serious events: 0 serious events

Other events: 56 other events

Deaths: 0 deaths

1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	H2O (2 mg IV Hydromorphone) n=166 participants at risk 2 mg IV hydromorphone H2O: 2 mg IV hydromorphone	1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone) n=168 participants at risk 1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?" 1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Endocrine disorders Administration of naloxone	0.00% 0/166 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)	0.00% 0/168 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)
Respiratory, thoracic and mediastinal disorders Oxygen saturation <95%	0.00% 0/166 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)	0.60% 1/168 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)
Cardiac disorders Pulse rate <50 beats/min	0.00% 0/166 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)	3.0% 5/168 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)
Vascular disorders Systolic blood pressure <90 mmHg	1.2% 2/166 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)	1.2% 2/168 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)
Skin and subcutaneous tissue disorders Pruritus	16.9% 28/166 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)	11.9% 20/168 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)
Gastrointestinal disorders Nausea	29.3% 17/58 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)	27.0% 17/63 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)
Gastrointestinal disorders Vomiting	15.5% 9/58 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)	12.7% 8/63 • 60 minutes The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following. H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7). 1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)

Additional Information

Dr. Andrew Chang

Montefiore Medical Center

Phone: 718-920-6626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place