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Intranasal Sufentanil Versus Intravenous Morphine for the Management of Acute Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03224039
Recruitment Status : Unknown
Verified July 2017 by Billy Sin, The Brooklyn Hospital Center.
Recruitment status was:  Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Billy Sin, The Brooklyn Hospital Center

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).


Condition or disease Intervention/treatment Phase
Acute Pain Drug: Sufentanil Drug: Normal saline Drug: Morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Comparison of Intranasal Sufentanil Versus Intravenous Morphine for the Management of Acute Pain
Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intranasal sufentanil

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
Intranasal for one dose (experimental)

Drug: Normal saline
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.

Active Comparator: Intravenous morphine

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
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.

Drug: Morphine
intravenous push for one dose (active comparator)




Primary Outcome Measures :
  1. Pain score [ Time Frame: 10 minutes after initiation of study intervention ]
    10 point Numeric Rating Scale will be used to assess pain


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: throughout study period (30 minutes) ]
    Incidence of adverse events in each group

  2. Mean dose of rescue analgesia required [ Time Frame: throughout study period (30 minutes) ]
    average dose of rescue analgesia required for both groups

  3. Patient satisfaction scores [ Time Frame: throughout study period (30 minutes) ]
    10 point (1-lowest, 10-highest) scores will be used

  4. Number of patients who required rescue analgesia [ Time Frame: throughout study period (30 minutes) ]
    number of patients within each group

  5. Length of stay [ Time Frame: throughout study period (30 minutes) ]
    ED length of study for each group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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
  • active breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224039


Contacts
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Contact: Billy Sin, PharmD 718-250-5000 ext 2450 bsin@tbh.org

Locations
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United States, New York
The Brooklyn Hospital Center Recruiting
Brooklyn, New York, United States, 11201
Contact: Billy W Sin, Pharm.D.    718-250-6250      
Contact: Michael Hochberg, MD    718-250-6202      
Sponsors and Collaborators
The Brooklyn Hospital Center

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Responsible Party: Billy Sin, Director, Emergency Medicine Clinical Research Program, The Brooklyn Hospital Center
ClinicalTrials.gov Identifier: NCT03224039    
Other Study ID Numbers: 954045-5
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Sufentanil
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics