Intranasal Sufentanil Versus Intravenous Morphine for the Management of Acute Pain

NCT ID: NCT03224039

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-01-01

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).

Detailed Description

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:

1. Treatment A:

1. Sufentanil 0.7 mcg/kg IN x 1dose (max of 1 mL administered per nostril)

2. Normal saline 1ml IV push x 1dose

2. Treatment B:

1. Normal saline 0.3 mL IN x 1 dose

2. Morphine 0.1 mg/kg IV push x 1dose

3. 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

1. Identification of patients with chief complaints or visit reasons of "acute pain", "musculoskeletal pain", "back pain", "abdominal pain", "fracture", "headache", "lacerations", and "sprains" via the Emergency Department's Status board by Research Associate (RA) or study investigators

2. Screening of potentially eligible patients with inclusion/exclusion criteria checklist via chart review by RA or study investigators.

3. If patient is eligible, the RA or study investigators will approach the medical resident or attending physician to confirm if the patient's visit reason is acute pain. If a medical decision is made by the attending or resident to treat the patient for acute pain, the RA (along with the medical resident, with approval from the attending physician) or study investigators will approach the patient to obtain informed consent and explain potential risks and benefits associated with receiving study interventions. Only study investigators will sign informed consent forms as per IRB protocol.

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).

5. Order will be placed in the electronic medical record (EMR) by the medical resident, attending physician, or pharmacist under the permission of the attending physician for a study intervention.

6. Upon receiving the medication order in the EMR, the order will be verified by the pharmacy. The pharmacy will then prepare either a sufentanil IN syringe and placebo injection or morphine injection and placebo IN syringe based on the study number assigned to the patient. The study investigators or RA assigned to the study will obtain the medication preparations from the pharmacy. Medication preparations will only be labeled with patient number and study number. No other identifying markers will be placed on the labels.

7. The nurse assigned to the patient or physician from the research team will administer the intervention medications. During administration of the intervention, the patient will be connected to a cardiac monitor for monitoring of possible cardiovascular adverse events.

8. An RA or study investigator will approach the patient to assess and record primary outcomes and secondary outcomes at designated time intervals. The data will be recorded on paper data collection sheets (see attached forms). The primary study investigator will not take part in data collection or analyses. If additional analgesic medications are requested by the patient, the orders will be placed by the medical resident or attending physician assigned to the patient.

9. All data collected on the paper data collection sheets will be transcribed into an encrypted and password protected electronic database by the RA. All patient identifiers will be de-identified in the database and all participants will be assigned a study participant number. This database will be stored on ED computers only and only RA's and study investigators will have access to it. The paper data collection sheets will be stored in a stationary, locked cabinet in the ED for safe keeping. At the end of the study, these records will be maintained according to the hospital's record-retention policy.

10. At the conclusion of study enrollment, an independent biostatistician will analyze the data. Only data from patients with diagnoses relating to acute pain and completed the study protocol without use of rescue analgesia during the designated time will be included in the study. Once the initial data analysis is complete, the log which details whether study participants received sufentanil IN or morphine IV will be revealed to the biostatistician for final data analysis and compilation.

11. At the conclusion of the study, final results and conclusions will be presented to the IRB. All data recorded on the paper data collection sheets will be destroyed and all data on the electronic databases will be deleted.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Sufentanil

Intervention Type: DRUG

Intranasal for one dose (experimental)

Normal saline

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: 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

Intervention Type: DRUG

intravenous push for one dose (active comparator)

Interventions

Sufentanil

Intranasal for one dose (experimental)

Intervention Type: 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.

Intervention Type: DRUG

Morphine

intravenous push for one dose (active comparator)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Brooklyn Hospital Center

OTHER

Sponsor Role: lead

Responsible Party

Billy Sin

Director, Emergency Medicine Clinical Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Brooklyn Hospital Center

Brooklyn, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Billy Sin, PharmD

Role: CONTACT

bsin@tbh.org

718-250-5000 ext. 2450

Facility Contacts

Billy W Sin, Pharm.D.

Role: primary

718-250-6250

Michael Hochberg, MD

Role: backup

718-250-6202

Other Identifiers

954045-5

Identifier Type: -

Identifier Source: org_study_id