A Phase 4 interventional study of Hydromorphone and Lidocaine in Abdominal Pain, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-10.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
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.
387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.
This study's enrollment of 154 is above the median of 70 across 290 interventional studies indexed under Abdominal Pain.
Browse Abdominal Pain studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 ( 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.
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.
Drug: Hydromorphone
Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes
Drug: Lidocaine
Hydromorphone intravenous infusion
Lidocaine intravenous infusion
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
Time frame: up to 90 minutes
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
Time frame: 4 hours
Adverse Events
Any new symptom development after administration of investigational medication
Time frame: 4 hours
| Milestone | Intravenous Hydromorphone | Intravenous Lidocaine |
|---|---|---|
| Started | 77 | 77 |
| Completed | 77 | 77 |
| Not completed | 0 | 0 |
Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable
| units on a scale | Intravenous Hydromorphone | Intravenous Lidocaine |
|---|---|---|
| Change in 0-10 Pain Scale Between Baseline and 90 Minutes | 5.0 ± 2.8 | 3.8 ± 2.2 |
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
| Participants | Intravenous Hydromorphone | Intravenous Lidocaine |
|---|---|---|
| Rescue Medication | 20 | 39 |
Any new symptom development after administration of investigational medication
| Participants | Intravenous Hydromorphone | Intravenous Lidocaine |
|---|---|---|
| Adverse Events | 28 | 23 |
Collected over 3 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intravenous Hydromorphone | 0/77 (0%) | 0/77 (0%) | 28/77 (36.4%) |
| Intravenous Lidocaine | 0/77 (0%) | 0/77 (0%) | 23/77 (29.9%) |
| Event | Intravenous Hydromorphone | Intravenous Lidocaine |
|---|---|---|
| dizzinessNervous system disorders | 14/77 | 4/77 |
| nauseaGastrointestinal disorders | 13/77 | 9/77 |
| drowsinessNervous system disorders | 6/77 | 4/77 |
| headacheNervous system disorders | 3/77 | 6/77 |
| Age, Continuous(years) | Intravenous Hydromorphone | Intravenous Lidocaine | Total |
|---|---|---|---|
| Mean | 40 ± 13 | 42 ± 12 | 41 ± 13 |
| Sex: Female, Male(Participants) | Intravenous Hydromorphone | Intravenous Lidocaine | Total |
|---|---|---|---|
| Female | 44 | 54 | 98 |
| Male | 33 | 23 | 56 |
| Race and Ethnicity Not Collected(Participants) | Intravenous Hydromorphone | Intravenous Lidocaine | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Intravenous Hydromorphone | Intravenous Lidocaine | Total |
|---|---|---|---|
| United States | 77 | 77 | 154 |
| Pain duration in days(days) | Intravenous Hydromorphone | Intravenous Lidocaine | Total |
|---|---|---|---|
| Median | 2 (1 to 3) | 2 (1 to 4) | 2 (1 to 4) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Hydromorphone · Lidocaine