Recruiting

Sufentanil vs. Morphine

Sponsor:

The Brooklyn Hospital Center

Code:

NCT03224039

Conditions

Acute Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sufentanil

Normal saline

Morphine

Study Details

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

Study ID

NCT03224039

Start date

Jan 1, 2017

Status verified date

Jul, 2017

Completion date

Jan 1, 2019

Anticipated

Primary completion date

Jan 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Sufentanil

Intranasal for one dose (experimental)

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.

Morphine

intravenous push for one dose (active comparator)

Primary outcome measure

  • Pain score [ Time Frame: 10 minutes after initiation of study intervention ]

Central Contacts and Locations

Central contacts

Billy Sin, PharmD

718-250-5000bsin@tbh.org

Locations

The Brooklyn Hospital Center

Recruiting

Brooklyn, New York, United States, 11201

Contacts

Billy W Sin, Pharm.D.

718-250-6250

Michael Hochberg, MD

718-250-6202

More Information

Sponsor

The Brooklyn Hospital Center

Last update posted

Jul 21, 2017

Last verified

Jul, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Brooklyn Hospital Center on 2017-07-21.