Intranasal Sufentanil Versus Intravenous Morphine for the Management of Acute Pain

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Acute Pain

In brief

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).

Key facts

Study ID

NCT03224039

Run by

The Brooklyn Hospital Center

People needed

40

Starts

2017-01-01

Expected to finish

2019-01-01

Last updated by the study team

2017-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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
• active breastfeeding.

Where it is running

• The Brooklyn Hospital Center — Brooklyn, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.