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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).
This study will be a single-center, randomized, controlled trial conducted in the Brooklyn Hospital Center's Emergency Department (ED)
Intervention:
Study participants will be randomized to receive one of the two study treatments below:
Treatment A:
Treatment B:
Rescue protocol:
Regardless of assignment to Treatment A or Treatment B, if severity of pain is ≥ 5 on the NRS, IV morphine dosed at 0.1 mg/kg IV push (max dose: 10 mg) may be administered at the discretion of the attending physician or medical resident assigned to the patient at designated intervals (5, 10, 20, and 30 minutes after administration of study treatment)
Process
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal sufentanil | Experimental | Treatment arm to include
|
|
| Intravenous morphine | Active Comparator | b. Treatment B:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil | Drug | Intranasal for one dose (experimental) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | 10 point Numeric Rating Scale will be used to assess pain | 10 minutes after initiation of study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence of adverse events in each group | throughout study period (30 minutes) |
| Mean dose of rescue analgesia required | average dose of rescue analgesia required for both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Billy Sin, PharmD | Contact | 718-250-5000 | 2450 | bsin@tbh.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Brooklyn Hospital Center | Recruiting | Brooklyn | New York | 11201 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 5, 2018 | |
| Reset | Jul 31, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 5, 2018 | Jul 31, 2018 |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D000077330 | Saline Solution |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
| 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. |
|
| Morphine | Drug | intravenous push for one dose (active comparator) |
|
| throughout study period (30 minutes) |
| Patient satisfaction scores | 10 point (1-lowest, 10-highest) scores will be used | throughout study period (30 minutes) |
| Number of patients who required rescue analgesia | number of patients within each group | throughout study period (30 minutes) |
| Length of stay | ED length of study for each group | throughout study period (30 minutes) |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |