Intranasal Sufentanil Versus Intravenous Morphine for the Management of Acute Pain

NCT03224039 | Unknown Phase 4 FDA Drug

• 1 other identifier: 954045-5
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a single-center, randomized, controlled trial conducted in the Brooklyn Hospital Center's Emergency Department (ED) expected to last 2 years. The sample size will be 40 patients with 20 patients in each treatment arm. The data points to be collected in the study are as follows: baseline characteristics (baseline pain score, date of birth, age, gender, weight and ethnicity), NRS pain scores at 5, 10, 20, and 30 minutes, dose of study treatment administered, incidence of adverse effects, time to patient discharge following administration of study treatment, patient satisfaction of pain control based on a 10-point Likert Scale, number of patients who required rescue analgesia, and amount of rescue analgesia required. 4. Once informed consent is obtained, patients will be randomized to receive Treatment A (sufentanil 0.7 mcg/kg intranasally (IN) and normal saline 1ml IV push) OR Treatment B (Normal saline 0.6 mL IN and morphine 0.1 mg/kg IV push). It should be noted that during the study period, use of additional morphine or adjuvant analgesics outside of the designated time intervals is allowed. The decision to use adjuvant analgesics is the decision of the attending physician assigned to the patient in the Emergency Department (ED).

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Pain score

  10 point Numeric Rating Scale will be used to assess pain

  10 minutes after initiation of study intervention

Secondary Outcomes (5)

• Adverse events

  throughout study period (30 minutes)

• Mean dose of rescue analgesia required

  throughout study period (30 minutes)

• Patient satisfaction scores

  throughout study period (30 minutes)

• Number of patients who required rescue analgesia

  throughout study period (30 minutes)

• Length of stay

  throughout study period (30 minutes)

Study Arms (2)

Intranasal sufentanil

EXPERIMENTAL

Treatment arm to include 1. Sufentanil 0.7 mcg/kg intranasal (IN) x 1 dose 2. Normal saline 1ml intravenous (IV) push x 1 dose

Drug: Sufentanil; Drug: Normal saline

Intravenous morphine

ACTIVE COMPARATOR

b. Treatment B: 1. Normal saline 0.3 mL IN x 1 dose 2. Morphine 0.1 mg/kg IV push x 1 dose

Drug: Normal saline; Drug: Morphine

Interventions

Sufentanil DRUG

Intranasal for one dose (experimental)

Intranasal sufentanil

Normal saline DRUG

Intravenous for one dose as placebo (to be administered with sufentanil or morphine arm as part of double-blinding). If patients are randomized to receive IN sufentanil, they will also receive IV normal saline. If patients are randomized to receive IV morphine, they will also receive IN normal saline.

Intranasal sufentanil; Intravenous morphine

Morphine DRUG

intravenous push for one dose (active comparator)

Intravenous morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• presenting to emergency department (ED) with chief complaint of acute generalized pain (including abdominal pain, headache, musculoskeletal pain, back pain, flank pain, joint sprains, lacerations, and fractures) with onset of within 6 hours
• pain score of 5 or greater on numerical pain scale (NRS)
• provides informed consent

You may not qualify if:

• reported or documented allergy to sufentanil, morphine, fentanyl, alfentanil, remifentanil, hydrocodone, codeine, hydromorphone, levorphanol, oxycodone, or oxymorphone,
• hemodynamic instability (defined as heart rate not within 60-110bpm
• respiratory rate not within 12-20 bpm
• blood pressure not within 90/50-180/100
• oxygen saturation not within 94-100%)
• refuse to provide "informed consent" form
• nasal obstruction/congestion
• complaint of chest pain
• recent head trauma/injury
• past medical history of hepatic impairment (including history of transplant), renal impairment or chronic renal disease (including history of transplant), chronic alcohol abuse, respiratory disease (ie. hypoxia, hypercapnia, COPD),
• seizure disorder
• thyroid disorders
• language barrier or inability to effectively communicate pain
• weighing \> 140 kg
• pregnancy

Sponsors & Collaborators

• The Brooklyn Hospital Center: lead

Study Sites (1)

The Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

RECRUITING

MeSH Terms

Conditions

Acute Pain

Interventions

Sufentanil; Saline Solution; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Billy Sin, PharmD

CONTACT

718-250-5000; bsin@tbh.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Assignment of treatment will be based on randomization. Each patient will be assigned a study number that would correspond to a specific treatment. Only the primary investigator (B.Sin) and the pharmacist procuring the study intervention will be unblinded to the treatment. The physician, nurse, research associate responsible for collecting data, and independent biostatistician responsible for interpreting the data will be blinded. Assignment of treatment will be placed in a opaque envelope where it would be opened only by the pharmacist will who be procuring the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Emergency Medicine Clinical Research Program

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)