Trial Outcomes & Findings for Protocolized vs Discretionary Use of Opioids in Acute Pain (NCT NCT00825370)
NCT ID: NCT00825370
Last Updated: 2018-06-12
Results Overview
Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
350 participants
Primary outcome timeframe
60 minutes
Results posted on
2018-06-12
Participant Flow
Participant milestones
| Measure |
Protocolized
1 mg IV 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?"
Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
|
Discretionary Care
Patients receive an IV opioid the type and dose of which is determined by the treating physician
IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
|
|---|---|---|
|
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
Protocolized vs Discretionary Use of Opioids in Acute Pain
Baseline characteristics by cohort
| Measure |
Protocolized
n=167 Participants
1 mg IV 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?"
Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
|
Discretionary Care
n=171 Participants
Patients receive an IV opioid the type and dose of which is determined by the treating physician
IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 11 • n=93 Participants
|
42 years
STANDARD_DEVIATION 13 • n=4 Participants
|
42 years
STANDARD_DEVIATION 12 • n=27 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
205 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
133 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
110 Participants
n=93 Participants
|
114 Participants
n=4 Participants
|
224 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
47 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
167 Participants
n=93 Participants
|
171 Participants
n=4 Participants
|
338 Participants
n=27 Participants
|
|
Weight
|
185 pounds
STANDARD_DEVIATION 52 • n=93 Participants
|
173 pounds
STANDARD_DEVIATION 44 • n=4 Participants
|
179 pounds
STANDARD_DEVIATION 48 • n=27 Participants
|
|
Location of pain
Abdomen
|
113 Participants
n=93 Participants
|
95 Participants
n=4 Participants
|
208 Participants
n=27 Participants
|
|
Location of pain
Other
|
54 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
130 Participants
n=27 Participants
|
|
Pain Intensity
3-7
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Pain Intensity
8
|
22 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Pain Intensity
9
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Pain Intensity
10
|
98 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
189 Participants
n=27 Participants
|
|
Nausea
|
62 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
|
Vomiting
|
46 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 60 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number of patients included in analysis is due to missing data (6 from Protocolized and 4 from Discretionary Care) and participants enrolled more than once (2 from Protocolized).
Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes
Outcome measures
| Measure |
Protocolized
n=167 Participants
1 mg IV 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?"
Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
|
Discretionary Care
n=171 Participants
Patients receive an IV opioid the type and dose of which is determined by the treating physician
IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
|
|---|---|---|
|
Percentage of Patients With Successful Treatment
|
86.8 Percentage of Participants
|
76.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: 15 minAs defined by the percentage of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes
Outcome measures
| Measure |
Protocolized
n=167 Participants
1 mg IV 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?"
Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
|
Discretionary Care
n=171 Participants
Patients receive an IV opioid the type and dose of which is determined by the treating physician
IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
|
|---|---|---|
|
Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes
|
73.7 Percentage of Participants
|
66.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: 60 minutesPatients who did not want pain medication determined by those who answered "no" to the question "do you want more pain medication?" at 60 minutes after treatment.
Outcome measures
| Measure |
Protocolized
n=167 Participants
1 mg IV 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?"
Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
|
Discretionary Care
n=171 Participants
Patients receive an IV opioid the type and dose of which is determined by the treating physician
IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
|
|---|---|---|
|
Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes
|
72.5 percentage of participants
|
63.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 60 minutesMean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The averages were calculated by finding the mean of change in pain intensity for each patient.
Outcome measures
| Measure |
Protocolized
n=167 Participants
1 mg IV 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?"
Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
|
Discretionary Care
n=171 Participants
Patients receive an IV opioid the type and dose of which is determined by the treating physician
IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
|
|---|---|---|
|
Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).
15 minutes
|
4.90 units on a scale
Standard Deviation 3.1
|
4.55 units on a scale
Standard Deviation 3.0
|
|
Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).
60 minutes
|
5.32 units on a scale
Standard Deviation 3.1
|
4.66 units on a scale
Standard Deviation 3.1
|
Adverse Events
Protocolized
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Discretionary Care
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Protocolized
n=167 participants at risk
1 mg IV 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?"
Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
|
Discretionary Care
n=171 participants at risk
Patients receive an IV opioid the type and dose of which is determined by the treating physician
IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
|
|---|---|---|
|
Endocrine disorders
Administration of Naloxone
|
0.00%
0/167 • 60 minutes
|
0.00%
0/171 • 60 minutes
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen saturation <95%
|
0.60%
1/167 • 60 minutes
|
1.2%
2/171 • 60 minutes
|
|
Vascular disorders
Systolic blood pressure <90 mmHg
|
1.8%
3/167 • 60 minutes
|
1.2%
2/171 • 60 minutes
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory rate <12 breaths/min
|
0.00%
0/167 • 60 minutes
|
1.2%
2/171 • 60 minutes
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
5/167 • 60 minutes
|
2.3%
4/171 • 60 minutes
|
|
Gastrointestinal disorders
Nausea
|
6.1%
5/82 • 60 minutes
|
14.7%
15/102 • 60 minutes
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
8/120 • 60 minutes
|
4.0%
5/125 • 60 minutes
|
Additional Information
Andrew Chang, MD, MS
Department of Emergency Medicine, Albert Einstein College of Medicine
Phone: 7189207464
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place