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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

224 participants

Primary outcome timeframe

60 minutes

Results posted on

2018-04-05

Participant Flow

Participant milestones

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

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
Age, Continuous	40 years STANDARD_DEVIATION 11 • n=5 Participants	41 years STANDARD_DEVIATION 12 • n=7 Participants	41 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	75 Participants n=7 Participants	141 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	35 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Black	25 Participants n=5 Participants	34 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	72 Participants n=5 Participants	66 Participants n=7 Participants	138 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	108 Participants n=5 Participants	110 Participants n=7 Participants	218 Participants n=5 Participants
Weight	179 lbs STANDARD_DEVIATION 52 • n=5 Participants	177 lbs STANDARD_DEVIATION 49 • n=7 Participants	178 lbs STANDARD_DEVIATION 51 • n=5 Participants
Location of Pain Abdomen	59 Participants n=5 Participants	73 Participants n=7 Participants	132 Participants n=5 Participants
Location of Pain Other	49 Participants n=5 Participants	37 Participants n=7 Participants	86 Participants n=5 Participants
Pain Intensity 3-7	8 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants
Pain Intensity 8	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants
Pain Intensity 9	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Pain Intensity 10	67 Participants n=5 Participants	55 Participants n=7 Participants	122 Participants n=5 Participants
Nausea/vomiting	44 Participants n=5 Participants	54 Participants n=7 Participants	98 Participants n=5 Participants
Analgesics taken at home	35 Participants n=5 Participants	26 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Population: Protocolized group had 4 missing outcome data, Nonprotocolized missing 2 outcome data. These 6 patients were excluded from the analysis.

Outcome measures

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 minutes

Population: 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).

Outcome measures

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 minutes

Population: 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).

Outcome measures

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 minutes

Population: 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

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

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Nonprotocolized

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	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

Phone: 718-920-7464

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place