Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department

Pain Clinical Trial

Official title:

Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03256487
• Other study ID #: IRB17-04172B
• Status: Recruiting
• Phase: Phase 2
• First received: August 18, 2017
• Last updated: October 17, 2017
• Start date: September 26, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: October 2017
• Source: Alameda Health System
• Contact: David Duong, MD MS
• Phone: 510-437-4573
• Email: dduong[@]alamedahealthsystem.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates intravenous (IV) buprenorphine versus IV morphine for the management of severe, acute pain among emergency department (ED) patients. ED patients with severe pain will be randomized in equal proportion to receive IV buprenorphine or IV morphine.

Description:

Buprenorphine is classified as a partial mu opioid agonist and a weak kappa antagonist. In lower doses, buprenorphine has an analgesic potency 25 to 40 times more potent than similar milligram dosages of morphine. Consistent with its partial agonist activity, an apparent ceiling effect for opioid-induced ventilatory impairment has been demonstrated. These properties would suggest that buprenorphine is an effective analgesic with a favorable safety profile.

Objective: The objective of this study is to determine if there is a clinically significant difference in reduction of pain scores, measured by the Numeric Rating Scale (NRS), between intravenous (IV) buprenorphine and IV morphine for severe pain in patients presenting to the Alameda Health System--Highland Hospital ED. The investigators are evaluating if IV buprenorphine is non-inferior to IV morphing. The investigators hypothesize that buprenorphine will provide equivalent analgesic effects as morphine at 60 minutes, with a lower proportion of medication adverse effects.

Study Design: This is a double-blinded, randomized controlled non-inferiority trial comparing the analgesic efficacy of intravenous buprenorphine versus intravenous morphine for ED patients presenting with severe, acute pain.

Participants: ED patients aged ≥18 years old who present with severe (pain NRS ≥7), acute pain warranting (according the treating provider's judgment) and able to receive IV opioid analgesia. The investigators will exclude pregnant patients, patients deemed too critically ill by the provider, patients with allergy to buprenorphine or morphine, patients in custody, patients on methadone, patients who have taken/received short acting opioid medications in the last 12 hours, and patients who have taken/received long acting opioid medication in the past 24 hours.

Intervention: In arm A, patients will receive IV Buprenorphine 0.3mg diluted to a volume of 10mL with NS in a plastic syringe administered over 3-5 minute. In arm B, patients will receive IV morphine 0.1mg/kg (max 10mg) over 3-5 minutes. In both arms, at 20 minutes the patient will be asked "would you like more pain medication?" If he/she answers "yes", then he/she will receive a second dose of the same amount of medication they previously received based on the randomized arm they were placed into. At the end of the study time, 60 minutes, the patient's ongoing pain management will be left to the attending physician caring for the patient in the ED.

Data Collection: For both arms, the patients' NRS pain scores and adverse effects will be queried at times 0, 10min, 20 min, 30min, 40min, 50 min, and 60 min. Demographic and comorbidity data points will be abstracted during or after the study's conclusion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: July 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ED patients with acute pain NRS =7 warranting IV opioid analgesia (according to ED provider)

Exclusion Criteria:

• Patient refusal

• pregnancy

• level 1 trauma patients

• patients deemed critically ill by provider

• patients in custody

• patients on methadone

• Patients who have received or taken any short acting opioid medication in the past 12 hours.

• Patients who have received or taken any long acting opioid medication in the past 24 hours.

Related Conditions & MeSH terms

• Emergencies
• Pain

Intervention

Drug:
• Buprenorphine
buprenorphine 0.3mg IV
• Morphine Sulfate
morphine 0.1 mg/kg IV (max 8mg per dose)

Locations

Country	Name	City	State
United States	Alameda Health System, Highland Hospital	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Alameda Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score difference at 60 minutes	The difference in pain scores (measured by NRS) between the two arms at 60 minutes.	60 minutes
Secondary	Pain score difference at 50 minutes	The difference in pain scores (measured by NRS) between the two arms.	50 minutes
Secondary	Pain score difference at 40 minutes	The difference in pain scores (measured by NRS) between the two arms.	40 minutes
Secondary	Pain score difference at 30 minutes	The difference in pain scores (measured by NRS) between the two arms.	30 minutes
Secondary	Pain score difference at 20 minutes	The difference in pain scores (measured by NRS) between the two arms.	20 minutes
Secondary	Pain score difference at 10 minutes	The difference in pain scores (measured by NRS) between the two arms.	10 minutes
Secondary	Adverse events	Hypertension (SBP > 180) from documented vital signs,hypotension (SBP <90) from documented vital signs, hypoxia (oxygen saturation < 90%), respiratory depression (RR<8 or need for mechanical intervention), nausea, vomiting, symptoms of opiate withdrawal (diarrhea, abdominal pain, diaphoresis)	10, 20, 30, 40, 50, and 60 minutes
Secondary	Pain reduction	Pain reduction at each time point. Measured by NRS (time 0) minus NRS (time x)	10, 20, 30, 40, 50, and 60 minutes
Secondary	Successful analgesia	Proportion of patients with NRS < 3 at 60 minutes	60 minutes
Secondary	Repeat dosing	Proportion of patients requiring reducing of analgesia at 20 minutes	20 minutes
Secondary	Summed Pain Intensity difference	Measurement combining relief magnitude and duration in a single score	60 minutes