Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, emergency department based, comparative effectiveness study of two medication for acute abdominal pain: intravenous lidocaine and intravenous hydromorphone. Patients will be enrolled during an emergency department visit and followed throughout their emergency department course and then by telephone 7 days later.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous hydromorphone | Active Comparator | Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. |
|
| Intravenous lidocaine | Active Comparator | Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | Hydromorphone intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 0-10 Pain Scale Between Baseline and 90 Minutes | Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable | up to 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Medication | no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug | 4 hours |
| Adverse Events |
Not provided
Inclusion Criteria:Eligible patients are those who present to an ED for treatment of acute abdominal pain. Acute will be defined as pain for no more than seven days. At the time of enrollment, the ED treatment plan must include use of an intravenous opioid.
Exclusion Criteria: Patients will be excluded from participation if they have cardiac conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, or PR interval duration > 0.2s), known renal (CKD >2) or liver disease (Childs-Pugh B or greater), are hemodynamically unstable, as determined by the attending physician, are pregnant or breastfeeding, or have a known allergy to either medication. Patients will also be excluded if they have used prescription or illicit opioids within the previous week, or if they have a chronic pain disorder, defined as use of any analgesic medication on more days than not during the month preceding the acute episode of pain. Patients weighing < 60kg or > 120kg will be excluded.
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30819520 | Derived | Chinn E, Friedman BW, Naeem F, Irizarry E, Afrifa F, Zias E, Jones MP, Pearlman S, Chertoff A, Wollowitz A, Gallagher EJ. Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department. Ann Emerg Med. 2019 Aug;74(2):233-240. doi: 10.1016/j.annemergmed.2019.01.021. Epub 2019 Feb 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Hydromorphone | Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. Hydromorphone: Hydromorphone intravenous infusion |
| FG001 | Intravenous Lidocaine | Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes Lidocaine: Lidocaine intravenous infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Hydromorphone | Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. Hydromorphone: Hydromorphone intravenous infusion |
| BG001 | Intravenous Lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 0-10 Pain Scale Between Baseline and 90 Minutes | Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable | Posted | Mean | Standard Deviation | units on a scale | up to 90 minutes |
|
3 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Hydromorphone | Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. Hydromorphone: Hydromorphone intravenous infusion |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Nervous system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin W. Friedman | Montefiore | 718-920-6626 | befriedm@montefiore.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2018 | Jul 28, 2020 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Double-blind
| Lidocaine |
| Drug |
Lidocaine intravenous infusion |
|
Any new symptom development after administration of investigational medication |
| 4 hours |
Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes
Lidocaine: Lidocaine intravenous infusion
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain duration in days | Median | Inter-Quartile Range | days |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Rescue Medication | no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug | Posted | Count of Participants | Participants | 4 hours |
|
|
|
| Secondary | Adverse Events | Any new symptom development after administration of investigational medication | Posted | Count of Participants | Participants | 4 hours |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 28 |
| 77 |
| EG001 | Intravenous Lidocaine | Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes Lidocaine: Lidocaine intravenous infusion | 0 | 77 | 0 | 77 | 23 | 77 |
| drowsiness | Nervous system disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D012817 | Signs and Symptoms, Digestive |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |