Trial Outcomes & Findings for Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain (NCT NCT00305110)
NCT ID: NCT00305110
Last Updated: 2018-08-20
Results Overview
Naloxone is a reversal agent - a medication that reverses the effects of another. Hydromorphone is an opiate pain medication that acts as a depressant to the body, thereby slowing it down. A large slow down is dangerous, as it can cause the breathing rate to slow down too much and prevent enough oxygen from entering the body and reaching the brain, resulting in death. Naloxone is a medication that blocks the receptors binding opiate pain medication and reversing the body's reaction to the hydromorphone, allowing body processes to return to normal speeds, including the breathing rate. The use of naloxone in the study indicates that the participant received too much pain medication or reacted more strongly than the average person, requiring the rescue medication to reverse the negative effects. The number of participants who required naloxone is assessed.
COMPLETED
PHASE2
298 participants
immediately after infusion, up to 120 minutes post infusion
2018-08-20
Participant Flow
Participant milestones
| Measure |
2 mg IV Hydromorphone
2 mg IV hydromorphone administered over 2-3 minutes
2 mg IV hydromorphone
|
|---|---|
|
Overall Study
STARTED
|
298
|
|
Overall Study
All Necessary Data Collected
|
269
|
|
Overall Study
COMPLETED
|
269
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
2 mg IV Hydromorphone
2 mg IV hydromorphone administered over 2-3 minutes
2 mg IV hydromorphone
|
|---|---|
|
Overall Study
Missing data
|
29
|
Baseline Characteristics
Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Baseline characteristics by cohort
| Measure |
2 mg IV Hydromorphone
n=269 Participants
2 mg IV hydromorphone administered over 2-3 minutes
2 mg IV hydromorphone
|
|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
163 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
269 Participants
n=5 Participants
|
|
Pain Location
Abdomen
|
205 Participants
n=5 Participants
|
|
Pain Location
Other
|
64 Participants
n=5 Participants
|
|
Baseline Pain intensity
less than 7
|
10 Participants
n=5 Participants
|
|
Baseline Pain intensity
7
|
22 Participants
n=5 Participants
|
|
Baseline Pain intensity
8
|
45 Participants
n=5 Participants
|
|
Baseline Pain intensity
9
|
33 Participants
n=5 Participants
|
|
Baseline Pain intensity
10
|
158 Participants
n=5 Participants
|
|
Weight
|
198 pounds
STANDARD_DEVIATION 38 • n=5 Participants
|
|
Final diagnosis
Abcess
|
7 Participants
n=5 Participants
|
|
Final diagnosis
Appendicitis
|
18 Participants
n=5 Participants
|
|
Final diagnosis
Biliary colic/cholecystitis
|
21 Participants
n=5 Participants
|
|
Final diagnosis
Diverticulitis
|
14 Participants
n=5 Participants
|
|
Final diagnosis
Gastritis
|
8 Participants
n=5 Participants
|
|
Final diagnosis
Kidney Stone
|
38 Participants
n=5 Participants
|
|
Final diagnosis
Low back pain
|
7 Participants
n=5 Participants
|
|
Final diagnosis
Nonspecific abdominal pain
|
65 Participants
n=5 Participants
|
|
Final diagnosis
Pancreatitis
|
9 Participants
n=5 Participants
|
|
Final diagnosis
Pyelonephritis
|
6 Participants
n=5 Participants
|
|
Final diagnosis
Small bowel obstruction
|
8 Participants
n=5 Participants
|
|
Final diagnosis
Other
|
68 Participants
n=5 Participants
|
|
Disposition
Admitted
|
122 Participants
n=5 Participants
|
|
Disposition
Discharged
|
144 Participants
n=5 Participants
|
|
Disposition
Against medical advice
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: immediately after infusion, up to 120 minutes post infusionNaloxone is a reversal agent - a medication that reverses the effects of another. Hydromorphone is an opiate pain medication that acts as a depressant to the body, thereby slowing it down. A large slow down is dangerous, as it can cause the breathing rate to slow down too much and prevent enough oxygen from entering the body and reaching the brain, resulting in death. Naloxone is a medication that blocks the receptors binding opiate pain medication and reversing the body's reaction to the hydromorphone, allowing body processes to return to normal speeds, including the breathing rate. The use of naloxone in the study indicates that the participant received too much pain medication or reacted more strongly than the average person, requiring the rescue medication to reverse the negative effects. The number of participants who required naloxone is assessed.
Outcome measures
| Measure |
2 mg IV Hydromorphone
n=269 Participants
2 mg IV hydromorphone administered over 2-3 minutes
2 mg IV hydromorphone
|
|---|---|
|
Number of Participants Requiring Naloxone
|
0 Participants
|
SECONDARY outcome
Timeframe: immediately after infusion, up to 120 minutes post infusionNormal respiratory rate ranges from 12 to 20 breaths per minute. The decreased respiration results in a decreased amount of oxygen entering the body and therefore low amount of oxygen supplied to the brain. Prolonged oxygen deprivation can result in injury or death. Respiratory rates lower than 12 breaths per minute is a sign of distress. Number of participants experiencing a respiratory rate lower than 12 breaths per minute is measured.
Outcome measures
| Measure |
2 mg IV Hydromorphone
n=269 Participants
2 mg IV hydromorphone administered over 2-3 minutes
2 mg IV hydromorphone
|
|---|---|
|
Number of Participants Experiencing a Respiratory Rate Lower Than 12 Breaths Per Minute
|
12 Participants
|
SECONDARY outcome
Timeframe: Immediately after infusion, up to 120 minutes post infusionNormal systolic blood pressure is approximately 120 mmHg. A low systolic blood pressure indicates blood, and therefore oxygen, are not being distributed around the body properly. This leads to a decreased amount of oxygen for the body to use and can result in injury or death if prolonged or severe.
Outcome measures
| Measure |
2 mg IV Hydromorphone
n=269 Participants
2 mg IV hydromorphone administered over 2-3 minutes
2 mg IV hydromorphone
|
|---|---|
|
Number of Participants Experiencing a Systolic Blood Pressure Less Than 90 mmHg
|
2 Participants
|
SECONDARY outcome
Timeframe: immediately after infusion, up to 120 minutes post infusionblood oxygen saturation less than 95% is considered oxygen desaturation. Blood oxygen saturation is normally above 95%. Oxygen desaturation of less than 90% is dangerous because there is less oxygen throughout the body for cellular energy. Prolonged or severe blood oxygen desaturation can result in injury or death.
Outcome measures
| Measure |
2 mg IV Hydromorphone
n=296 Participants
2 mg IV hydromorphone administered over 2-3 minutes
2 mg IV hydromorphone
|
|---|---|
|
Oxygen Desaturation Measured Over 2-hour Time Frame
at least 95% oxygen saturation, all time points
|
68 participants
Interval 62.0 to 73.0
|
|
Oxygen Desaturation Measured Over 2-hour Time Frame
90-94% oxygen saturation, one or more times
|
26 participants
Interval 21.0 to 32.0
|
|
Oxygen Desaturation Measured Over 2-hour Time Frame
below 90% oxygen saturation, one or more times
|
6 participants
Interval 4.0 to 10.0
|
SECONDARY outcome
Timeframe: baseline to 120 minutes post infusionblood oxygen saturation is measured periodically from 1 minute to 120 minutes after the medication was infused
Outcome measures
| Measure |
2 mg IV Hydromorphone
n=269 Participants
2 mg IV hydromorphone administered over 2-3 minutes
2 mg IV hydromorphone
|
|---|---|
|
Oxygen Saturation Measured Over 2-hour Time Frame
30 minutes post infusion
|
98 % oxygen saturation
Interval 96.0 to 99.0
|
|
Oxygen Saturation Measured Over 2-hour Time Frame
Baseline
|
99 % oxygen saturation
Interval 98.0 to 100.0
|
|
Oxygen Saturation Measured Over 2-hour Time Frame
1 minute post infusion
|
98 % oxygen saturation
Interval 96.0 to 99.0
|
|
Oxygen Saturation Measured Over 2-hour Time Frame
2 minutes post infusion
|
98 % oxygen saturation
Interval 96.0 to 99.0
|
|
Oxygen Saturation Measured Over 2-hour Time Frame
3 minutes post infusion
|
98 % oxygen saturation
Interval 96.0 to 99.0
|
|
Oxygen Saturation Measured Over 2-hour Time Frame
4 minutes post infusion
|
98 % oxygen saturation
Interval 96.0 to 99.0
|
|
Oxygen Saturation Measured Over 2-hour Time Frame
5 minutes post infusion
|
97 % oxygen saturation
Interval 96.0 to 99.0
|
|
Oxygen Saturation Measured Over 2-hour Time Frame
15 minutes post infusion
|
97 % oxygen saturation
Interval 96.0 to 99.0
|
|
Oxygen Saturation Measured Over 2-hour Time Frame
120 minutes post infusion
|
98 % oxygen saturation
Interval 97.0 to 99.0
|
POST_HOC outcome
Timeframe: baseline up to 120 minutes after post infusionPain intensity is measured on the numerical rating scale (NRS), from 0 ("no pain") to 10 ("worst pain possible"). Participants are asked to rate their pain periodically over a 2 hour time period following infusion of the medication.
Outcome measures
| Measure |
2 mg IV Hydromorphone
n=269 Participants
2 mg IV hydromorphone administered over 2-3 minutes
2 mg IV hydromorphone
|
|---|---|
|
Pain Intensity Assessed Over 2-hour Time Frame
Baseline
|
10 units on a scale
Interval 8.0 to 10.0
|
|
Pain Intensity Assessed Over 2-hour Time Frame
1 minute post infusion
|
4 units on a scale
Interval 0.0 to 7.0
|
|
Pain Intensity Assessed Over 2-hour Time Frame
2 minutes post infusion
|
3 units on a scale
Interval 0.0 to 6.0
|
|
Pain Intensity Assessed Over 2-hour Time Frame
3 minutes post infustion
|
3 units on a scale
Interval 0.0 to 5.0
|
|
Pain Intensity Assessed Over 2-hour Time Frame
4 minutes post infusion
|
2 units on a scale
Interval 0.0 to 5.0
|
|
Pain Intensity Assessed Over 2-hour Time Frame
5 minutes post infusion
|
1 units on a scale
Interval 0.0 to 5.0
|
|
Pain Intensity Assessed Over 2-hour Time Frame
15 minutes post infusion
|
1 units on a scale
Interval 0.0 to 4.0
|
|
Pain Intensity Assessed Over 2-hour Time Frame
30 minutes post infusion
|
0 units on a scale
Interval 0.0 to 3.0
|
|
Pain Intensity Assessed Over 2-hour Time Frame
120 minutes post infusion
|
1 units on a scale
Interval 0.0 to 4.0
|
Adverse Events
2 mg IV Hydromorphone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2 mg IV Hydromorphone
n=269 participants at risk
2 mg IV hydromorphone administered over 2-3 minutes
2 mg IV hydromorphone
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Rate <12 breathes per minute
|
4.5%
12/269 • 120 minutes
|
|
Vascular disorders
Heart Rate <60 beats/min
|
12.6%
34/269 • 120 minutes
|
|
Vascular disorders
Systolic blood pressure <90 mmHg
|
0.74%
2/269 • 120 minutes
|
|
Gastrointestinal disorders
Nausea
|
16.8%
21/125 • 120 minutes
|
|
Gastrointestinal disorders
Vomiting
|
7.2%
9/125 • 120 minutes
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
8.2%
22/269 • 120 minutes
|
Additional Information
Andrew Chang, MD, MS
Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place