Trial Outcomes & Findings for High Dose IV Lidocaine vs Hydromorphone for Abdominal Pain in the Emergency Department (NCT NCT04398316)
NCT ID: NCT04398316
Last Updated: 2024-01-17
Results Overview
The difference between the pain score at time 0 and 90 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
90 minutes
Results posted on
2024-01-17
Participant Flow
Participant milestones
| Measure |
Intravenous Lidocaine
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Dose IV Lidocaine vs Hydromorphone for Abdominal Pain in the Emergency Department
Baseline characteristics by cohort
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.33 years
STANDARD_DEVIATION 13.58 • n=5 Participants
|
61 years
STANDARD_DEVIATION 0 • n=7 Participants
|
43.25 years
STANDARD_DEVIATION 16.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White (Caucasian, Non-Hispanic)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black (African American or African)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian (Native American) or Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 minutesThe difference between the pain score at time 0 and 90 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Mean Improvement in Pain at 90 Minutes
|
3.67 score on a scale
Standard Deviation 3.51
|
-1 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From administration of study drug until patient leaves the emergency department, up until 3 hours from administration of study drug.Does the patient require off-protocol medication for additional pain relief? Off-protocol defined as any opiate or NSAID
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Sufficient Pain Relief
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 15 minutesThe difference between the pain score at time 0 and 15 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Improvement in Numerical Pain Score at 15 Minutes
|
4.33 score on a scale
Standard Deviation 3.51
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 30 minutesThe difference between the pain score at time 0 and 30 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Improvement in Numerical Pain Score at 30 Minutes
|
2.33 score on a scale
Standard Deviation 1.53
|
1 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 60 minutesThe difference between the pain score at time 0 and 60 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Improvement in Numerical Pain Score at 60 Minutes
|
4 score on a scale
Standard Deviation 3
|
1 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 120 minutesThe difference between the pain score at time 0 and 120 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Improvement in Numerical Pain Score at 120 Minutes
|
4 score on a scale
Standard Deviation 3
|
-2 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 150 minutesThe difference between the pain score at time 0 and 150 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Improvement in Numerical Pain Score at 150 Minutes
|
3.33 score on a scale
Standard Deviation 2.08
|
-2 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 180 minutesThe difference between the pain score at time 0 and 180 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Improvement in Numerical Pain Score at 180 Minutes
|
3.33 score on a scale
Standard Deviation 2.08
|
-2 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 7If the patient were to come to the ED again for the same complaint, would they want the same study drug they received?
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Patient Preference for the Medication They Received
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes and at 7 daysYes or no, did the patient have any side effects, defined as any new symptom after the administration of the study drug.
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Side Effects
15 Minutes · None
|
2 Participants
|
1 Participants
|
|
Side Effects
15 Minutes · Nausea
|
0 Participants
|
0 Participants
|
|
Side Effects
15 Minutes · Vomiting
|
0 Participants
|
0 Participants
|
|
Side Effects
15 Minutes · Dizziness
|
0 Participants
|
0 Participants
|
|
Side Effects
15 Minutes · Lightheadedness
|
0 Participants
|
0 Participants
|
|
Side Effects
15 Minutes · Paresthesia
|
0 Participants
|
0 Participants
|
|
Side Effects
15 Minutes · Weakness
|
0 Participants
|
0 Participants
|
|
Side Effects
15 Minutes · Slurred speech
|
0 Participants
|
0 Participants
|
|
Side Effects
15 Minutes · Feeling tired
|
0 Participants
|
0 Participants
|
|
Side Effects
15 Minutes · Headache
|
1 Participants
|
0 Participants
|
|
Side Effects
15 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Side Effects
30 Minutes · None
|
2 Participants
|
1 Participants
|
|
Side Effects
30 Minutes · Nausea
|
0 Participants
|
0 Participants
|
|
Side Effects
30 Minutes · Vomiting
|
0 Participants
|
0 Participants
|
|
Side Effects
30 Minutes · Dizziness
|
0 Participants
|
0 Participants
|
|
Side Effects
30 Minutes · Lightheadedness
|
0 Participants
|
0 Participants
|
|
Side Effects
30 Minutes · Paresthesia
|
0 Participants
|
0 Participants
|
|
Side Effects
30 Minutes · Weakness
|
0 Participants
|
0 Participants
|
|
Side Effects
30 Minutes · Slurred speech
|
0 Participants
|
0 Participants
|
|
Side Effects
30 Minutes · Feeling tired
|
0 Participants
|
0 Participants
|
|
Side Effects
30 Minutes · Headache
|
1 Participants
|
0 Participants
|
|
Side Effects
30 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Side Effects
60 Minutes · None
|
1 Participants
|
1 Participants
|
|
Side Effects
60 Minutes · Nausea
|
0 Participants
|
0 Participants
|
|
Side Effects
60 Minutes · Vomiting
|
0 Participants
|
0 Participants
|
|
Side Effects
60 Minutes · Dizziness
|
0 Participants
|
0 Participants
|
|
Side Effects
60 Minutes · Lightheadedness
|
0 Participants
|
0 Participants
|
|
Side Effects
60 Minutes · Paresthesia
|
0 Participants
|
0 Participants
|
|
Side Effects
60 Minutes · Weakness
|
0 Participants
|
0 Participants
|
|
Side Effects
60 Minutes · Slurred speech
|
0 Participants
|
0 Participants
|
|
Side Effects
60 Minutes · Feeling tired
|
1 Participants
|
0 Participants
|
|
Side Effects
60 Minutes · Headache
|
1 Participants
|
0 Participants
|
|
Side Effects
60 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Side Effects
90 Minutes · None
|
1 Participants
|
1 Participants
|
|
Side Effects
90 Minutes · Nausea
|
1 Participants
|
0 Participants
|
|
Side Effects
90 Minutes · Vomiting
|
0 Participants
|
0 Participants
|
|
Side Effects
90 Minutes · Dizziness
|
0 Participants
|
0 Participants
|
|
Side Effects
90 Minutes · Lightheadedness
|
0 Participants
|
0 Participants
|
|
Side Effects
90 Minutes · Paresthesia
|
1 Participants
|
0 Participants
|
|
Side Effects
90 Minutes · Weakness
|
0 Participants
|
0 Participants
|
|
Side Effects
90 Minutes · Slurred speech
|
0 Participants
|
0 Participants
|
|
Side Effects
90 Minutes · Feeling tired
|
0 Participants
|
0 Participants
|
|
Side Effects
90 Minutes · Headache
|
0 Participants
|
0 Participants
|
|
Side Effects
90 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Side Effects
120 Minutes · None
|
3 Participants
|
1 Participants
|
|
Side Effects
120 Minutes · Nausea
|
0 Participants
|
0 Participants
|
|
Side Effects
120 Minutes · Vomiting
|
0 Participants
|
0 Participants
|
|
Side Effects
120 Minutes · Dizziness
|
0 Participants
|
0 Participants
|
|
Side Effects
120 Minutes · Lightheadedness
|
0 Participants
|
0 Participants
|
|
Side Effects
120 Minutes · Paresthesia
|
0 Participants
|
0 Participants
|
|
Side Effects
120 Minutes · Weakness
|
0 Participants
|
0 Participants
|
|
Side Effects
120 Minutes · Slurred speech
|
0 Participants
|
0 Participants
|
|
Side Effects
120 Minutes · Feeling tired
|
0 Participants
|
0 Participants
|
|
Side Effects
120 Minutes · Headache
|
0 Participants
|
0 Participants
|
|
Side Effects
120 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Side Effects
150 Minutes · None
|
3 Participants
|
1 Participants
|
|
Side Effects
150 Minutes · Nausea
|
0 Participants
|
0 Participants
|
|
Side Effects
150 Minutes · Vomiting
|
0 Participants
|
0 Participants
|
|
Side Effects
150 Minutes · Dizziness
|
0 Participants
|
0 Participants
|
|
Side Effects
150 Minutes · Lightheadedness
|
0 Participants
|
0 Participants
|
|
Side Effects
150 Minutes · Paresthesia
|
0 Participants
|
0 Participants
|
|
Side Effects
150 Minutes · Weakness
|
0 Participants
|
0 Participants
|
|
Side Effects
150 Minutes · Slurred speech
|
0 Participants
|
0 Participants
|
|
Side Effects
150 Minutes · Feeling tired
|
0 Participants
|
0 Participants
|
|
Side Effects
150 Minutes · Headache
|
0 Participants
|
0 Participants
|
|
Side Effects
150 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Side Effects
180 Minutes · None
|
3 Participants
|
1 Participants
|
|
Side Effects
180 Minutes · Nausea
|
0 Participants
|
0 Participants
|
|
Side Effects
180 Minutes · Vomiting
|
0 Participants
|
0 Participants
|
|
Side Effects
180 Minutes · Dizziness
|
0 Participants
|
0 Participants
|
|
Side Effects
180 Minutes · Lightheadedness
|
0 Participants
|
0 Participants
|
|
Side Effects
180 Minutes · Paresthesia
|
0 Participants
|
0 Participants
|
|
Side Effects
180 Minutes · Weakness
|
0 Participants
|
0 Participants
|
|
Side Effects
180 Minutes · Slurred speech
|
0 Participants
|
0 Participants
|
|
Side Effects
180 Minutes · Feeling tired
|
0 Participants
|
0 Participants
|
|
Side Effects
180 Minutes · Headache
|
0 Participants
|
0 Participants
|
|
Side Effects
180 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Side Effects
7 Days · None
|
3 Participants
|
0 Participants
|
|
Side Effects
7 Days · Nausea
|
0 Participants
|
1 Participants
|
|
Side Effects
7 Days · Vomiting
|
0 Participants
|
0 Participants
|
|
Side Effects
7 Days · Dizziness
|
0 Participants
|
0 Participants
|
|
Side Effects
7 Days · Lightheadedness
|
0 Participants
|
0 Participants
|
|
Side Effects
7 Days · Paresthesia
|
0 Participants
|
0 Participants
|
|
Side Effects
7 Days · Weakness
|
0 Participants
|
0 Participants
|
|
Side Effects
7 Days · Slurred speech
|
0 Participants
|
0 Participants
|
|
Side Effects
7 Days · Feeling tired
|
0 Participants
|
0 Participants
|
|
Side Effects
7 Days · Headache
|
0 Participants
|
0 Participants
|
|
Side Effects
7 Days · Other
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutesAre any medications required to control medication side effects, defined as any new symptom after the administration of the study drug?
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Medication for Side Effects
15 Minutes · None
|
3 Participants
|
1 Participants
|
|
Medication for Side Effects
15 Minutes · Diphenhydramine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
15 Minutes · Ondansetron
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
15 Minutes · Metoclopramide
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
15 Minutes · Droperidol
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
15 Minutes · Promethazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
15 Minutes · Prochlorperazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
15 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
30 Minutes · None
|
3 Participants
|
1 Participants
|
|
Medication for Side Effects
30 Minutes · Diphenhydramine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
30 Minutes · Ondansetron
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
30 Minutes · Metoclopramide
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
30 Minutes · Droperidol
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
30 Minutes · Promethazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
30 Minutes · Prochlorperazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
30 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
60 Minutes · None
|
3 Participants
|
1 Participants
|
|
Medication for Side Effects
60 Minutes · Diphenhydramine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
60 Minutes · Ondansetron
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
60 Minutes · Metoclopramide
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
60 Minutes · Droperidol
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
60 Minutes · Promethazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
60 Minutes · Prochlorperazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
60 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
90 Minutes · None
|
2 Participants
|
1 Participants
|
|
Medication for Side Effects
90 Minutes · Diphenhydramine
|
1 Participants
|
0 Participants
|
|
Medication for Side Effects
90 Minutes · Ondansetron
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
90 Minutes · Metoclopramide
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
90 Minutes · Droperidol
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
90 Minutes · Promethazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
90 Minutes · Prochlorperazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
90 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
120 Minutes · None
|
3 Participants
|
1 Participants
|
|
Medication for Side Effects
120 Minutes · Diphenhydramine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
120 Minutes · Ondansetron
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
120 Minutes · Metoclopramide
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
120 Minutes · Droperidol
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
120 Minutes · Promethazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
120 Minutes · Prochlorperazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
120 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
150 Minutes · None
|
3 Participants
|
1 Participants
|
|
Medication for Side Effects
150 Minutes · Diphenhydramine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
150 Minutes · Ondansetron
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
150 Minutes · Metoclopramide
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
150 Minutes · Droperidol
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
150 Minutes · Promethazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
150 Minutes · Prochlorperazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
150 Minutes · Other
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
180 Minutes · None
|
3 Participants
|
1 Participants
|
|
Medication for Side Effects
180 Minutes · Diphenhydramine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
180 Minutes · Ondansetron
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
180 Minutes · Metoclopramide
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
180 Minutes · Droperidol
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
180 Minutes · Promethazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
180 Minutes · Prochlorperazine
|
0 Participants
|
0 Participants
|
|
Medication for Side Effects
180 Minutes · Other
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutesYes or no, was naloxone required after the patient received the study drug?
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Administration of Naloxone
Yes
|
0 Participants
|
0 Participants
|
|
Administration of Naloxone
No
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutesYes or no, did the patients disposition change as a consequence of administration of the study drug? Example would be an adverse outcome resulting in hospitalization or other escalation of care.
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Change in Disposition
Yes
|
0 Participants
|
0 Participants
|
|
Change in Disposition
No
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 days after administration of study drugYes or no, did the patient have a new diagnosis within the next week?
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Missed Diagnosis
Yes
|
0 Participants
|
1 Participants
|
|
Missed Diagnosis
No
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 minutes after administration of study drugYes or no, did the patient suffer a serious adverse event? Defined as death, requiring or prolonging inpatient hospitalization, resulting in persistent or significant disability/incapacity, or is considered a significant medical event by the investigator based off of medical judgement.
Outcome measures
| Measure |
Intravenous Lidocaine
n=3 Participants
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 Participants
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Serious Adverse Event
Yes
|
0 Participants
|
0 Participants
|
|
Serious Adverse Event
No
|
3 Participants
|
1 Participants
|
Adverse Events
Intravenous Lidocaine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Intravenous Hydromorphone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intravenous Lidocaine
n=3 participants at risk
Administered at a dose of 2 mg/kg over 5 minutes
Lidocaine Iv: 2 mg/kg over 5 minutes
|
Intravenous Hydromorphone
n=1 participants at risk
Administered at a dose of 1 mg over 5 minutes
HYDROmorphone Injection: 1 mg over 5 minutes
|
|---|---|---|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Subjects were monitored for the first 180 minutes they were in the emergency department. They were followed up to 7 days later.
|
0.00%
0/1 • Subjects were monitored for the first 180 minutes they were in the emergency department. They were followed up to 7 days later.
|
|
General disorders
Feeling tired
|
33.3%
1/3 • Number of events 1 • Subjects were monitored for the first 180 minutes they were in the emergency department. They were followed up to 7 days later.
|
0.00%
0/1 • Subjects were monitored for the first 180 minutes they were in the emergency department. They were followed up to 7 days later.
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • Subjects were monitored for the first 180 minutes they were in the emergency department. They were followed up to 7 days later.
|
0.00%
0/1 • Subjects were monitored for the first 180 minutes they were in the emergency department. They were followed up to 7 days later.
|
Additional Information
Elliott Chinn, DO
Hennepin County Medical Center, Department of Emergency Medicine
Phone: 612-873-3508
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place