Trial Outcomes & Findings for Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain (NCT NCT00627367)
NCT ID: NCT00627367
Last Updated: 2018-04-05
Results Overview
Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline NRS score (before treatment in the Emergency Department).
COMPLETED
PHASE3
224 participants
60 minutes
2018-04-05
Participant Flow
Participant milestones
| Measure |
Protocolized
1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?"
Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
|
Nonprotocolized
An IV opioid the type and dose of which will be determined by the treating clincian
Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
112
|
|
Overall Study
COMPLETED
|
112
|
112
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain
Baseline characteristics by cohort
| Measure |
Protocolized
n=108 Participants
1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?"
Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
|
Nonprotocolized
n=110 Participants
An IV opioid the type and dose of which will be determined by the treating clincian
Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Pain Intensity
8
|
22 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 11 • n=99 Participants
|
41 years
STANDARD_DEVIATION 12 • n=107 Participants
|
41 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
25 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
72 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
108 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
218 Participants
n=206 Participants
|
|
Weight
|
179 lbs
STANDARD_DEVIATION 52 • n=99 Participants
|
177 lbs
STANDARD_DEVIATION 49 • n=107 Participants
|
178 lbs
STANDARD_DEVIATION 51 • n=206 Participants
|
|
Location of Pain
Abdomen
|
59 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Location of Pain
Other
|
49 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Pain Intensity
3-7
|
8 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Pain Intensity
9
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Pain Intensity
10
|
67 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Nausea/vomiting
|
44 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Analgesics taken at home
|
35 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 60 minutesPopulation: Protocolized group had 4 missing outcome data, Nonprotocolized missing 2 outcome data. These 6 patients were excluded from the analysis.
Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline NRS score (before treatment in the Emergency Department).
Outcome measures
| Measure |
Protocolized
n=108 Participants
1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?"
Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
|
Nonprotocolized
n=110 Participants
An IV opioid the type and dose of which will be determined by the treating clincian
Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician
|
|---|---|---|
|
Patient Reported Change in Pain Intensity From Initial Administration of Analgesics (Baseline) to 60 Minutes Post-baseline.
|
5.5 units on a scale
Standard Deviation 2.9
|
4.5 units on a scale
Standard Deviation 3.0
|
POST_HOC outcome
Timeframe: 60 minutesPopulation: Change in N from total analyzed (82 and 99 from 108 and 110 respectively) due to looking at a subpopulation: those patients who only received 1 dose of IV hydromorphone, versus those who received 2 or more doses (see 3. Post Hoc Outcome).
Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department).
Outcome measures
| Measure |
Protocolized
n=82 Participants
1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?"
Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
|
Nonprotocolized
n=99 Participants
An IV opioid the type and dose of which will be determined by the treating clincian
Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician
|
|---|---|---|
|
Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 1 Dose of Intravenous (IV) Hydromorphone
|
6.1 units on a scale
Standard Deviation 4.0
|
4.5 units on a scale
Standard Deviation 3.1
|
POST_HOC outcome
Timeframe: 60 minutesPopulation: Change in N from total analyzed (26 and 22 from 108 and 110 respectively) due to looking at a subpopulation: those patients who received 2 or more doses of IV hydromorphone, versus those who received only 1 dose (see 2. Post Hoc Outcome).
Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department).
Outcome measures
| Measure |
Protocolized
n=26 Participants
1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?"
Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
|
Nonprotocolized
n=11 Participants
An IV opioid the type and dose of which will be determined by the treating clincian
Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician
|
|---|---|---|
|
Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 2 Doses of Intravenous (IV) Hydromorphone
|
4.0 units on a scale
Standard Deviation 3.2
|
4.3 units on a scale
Standard Deviation 3.3
|
POST_HOC outcome
Timeframe: 60 minutesPopulation: The Nonprotocolized group has a different value for participants analyzed for this section than the overall number of participants analyzed for the group (81 versus 110), because this is looking at only those patients who received IV morphine. Nonprotocolized left medication up to the doctor, and as such, some patients received different medication
Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department). The comparison of hydromorphone to morphine is due to the wide use of morphine for pain management in the Emergency Department setting and the comparison of the two opioids in previous studies.
Outcome measures
| Measure |
Protocolized
n=108 Participants
1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?"
Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
|
Nonprotocolized
n=81 Participants
An IV opioid the type and dose of which will be determined by the treating clincian
Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician
|
|---|---|---|
|
Change in Numerical Rating Scale (NRS) Scores Among Patients in the Protocolized Group vs Those in the Physician Driven Group Who Received Only Intravenous (IV) Morphine
|
5.6 units on a scale
Standard Deviation 3.2
|
4.4 units on a scale
Standard Deviation 2.8
|
Adverse Events
Protocolized
Nonprotocolized
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Protocolized
n=108 participants at risk
1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?"
Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
|
Nonprotocolized
n=110 participants at risk
An IV opioid the type and dose of which will be determined by the treating clincian
Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oxygen saturation <90%
|
0.00%
0/108 • 60 minutes after the last dose of opioids was given
|
1.8%
2/110 • 60 minutes after the last dose of opioids was given
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen saturation 90-94%
|
4.6%
5/108 • 60 minutes after the last dose of opioids was given
|
1.8%
2/110 • 60 minutes after the last dose of opioids was given
|
|
Vascular disorders
Pulse rate <60 beats/min
|
3.8%
4/106 • 60 minutes after the last dose of opioids was given
|
8.5%
9/106 • 60 minutes after the last dose of opioids was given
|
|
Vascular disorders
Systolic blood pressure <90 mmHg
|
1.9%
2/108 • 60 minutes after the last dose of opioids was given
|
2.8%
3/108 • 60 minutes after the last dose of opioids was given
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory rate <12 breaths /min
|
0.93%
1/108 • 60 minutes after the last dose of opioids was given
|
0.91%
1/110 • 60 minutes after the last dose of opioids was given
|
|
Gastrointestinal disorders
Nausea
|
17.2%
11/64 • 60 minutes after the last dose of opioids was given
|
8.9%
5/56 • 60 minutes after the last dose of opioids was given
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
3/64 • 60 minutes after the last dose of opioids was given
|
1.8%
1/56 • 60 minutes after the last dose of opioids was given
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
7/108 • 60 minutes after the last dose of opioids was given
|
3.6%
4/110 • 60 minutes after the last dose of opioids was given
|
Additional Information
Andrew Chang, MD, MS
Department of Emergency Medicine, Albert Einstein College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place