Intravenous Lidocaine Randomized Comparative Effectiveness Trial

Abdominal Pain Clinical Trial

Official title:

Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain. A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300674
• Other study ID #: 2017-8408
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2018
• Est. completion date: August 28, 2018

Study information

• Verified date: July 2020
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 28, 2018
• Est. primary completion date: August 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Drug:
• Hydromorphone
Hydromorphone intravenous infusion
• Lidocaine
Lidocaine intravenous infusion

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	up to 90 minutes
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	4 hours
Secondary	Adverse Events	Any new symptom development after administration of investigational medication	4 hours