Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain
Condition: Pain, Fracture, Sprain
MeSH terms: Fractures, Avulsion
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does
      the comparator Percocet
    

Detailed description: 
      Patients will be initially deemed eligible for study consideration if, after MGH ED nursing
      triage, an X-ray is ordered for suspected isolated extremity injury and the triage acuity
      level is "Minor". Study staff (physicians) will monitor the ED registration and triage areas
      to assess whether triaged patients are potentially eligible.

      For ED patients with minor isolated injuries, X-rays are often ordered from triage, where
      there is a supervising physician (or nurse practitioner) available to examine patients and
      direct care. Either at triage (for patients undergoing care at that location) or when
      patients are moved to the ED's Minor Surgery area, the supervising healthcare provider will
      be approached immediately after that individual's evaluation of the patient, and before any
      pain medication is administered, to begin the process of eligibility ascertainment.

      If the provider agrees that the patient may be a candidate for the study, the next step will
      be for the provider to ask the patient if study staff may approach to discuss the trial.

      If the patient agrees to have study staff approach to discuss the trial, study personnel (all
      EM resident or Attending-level physicians) will be introduced by healthcare providers to
      potential subjects. Study staff will then converse with the patients about the study's aims,
      methodology, and risks, confirming eligibility and determining if patients will consent to
      participate.

      Patients who are approached, but who are determined to be ineligible, will have no data
      recorded, other than their age and race/ethnicity and the reason they were ineligible.

      If eligible patients provide written consent in the manner and form dictated by Partners
      guidelines, the study procedures will commence.

      For eligible patients who do not give consent, study physicians will emphasize that patient
      care will be unaffected by their decision. No further contact will occur between study staff
      and those patients. No identifying information about such patients will be recorded, but
      their age and race/ethnicity will be recorded. (Recording this information will allow for
      subsequent assessment for selection bias, and will also help search for patterns in patient
      types refusing analgesia trial participation.)

      The actual medication administration will involve the following steps:

        1. Patients participating in the study will be identified and placed in a "room" (stretcher
           or actual ED room) in the MGH ED's Minor Multipurpose (MIMP) area;

        2. RNs will obtain the study medication pairs (buccal tablet + oral tablet) from the
           computerized medication storage area - RNs will take the next-numbered medication pair
           from the MGH Research Pharmacy-prepared drug packaging;

        3. Actual medications will be administered by a licensed physician (a study
           co-investigator, EM resident or Attending physician at MGH), who is not the
           co-investigator monitoring the patient for endpoint assessment - the physician
           administering the medication/placebo will inform neither the patient nor the clinical or
           study staff, the identity of the medication/placebo pair given.

      Patients will be monitored by a study physician co-investigator physically present with the
      patient, for a total of 120 minutes after administration of medication. They will be asked
      q-5-minutes, through 60 minutes, to rate their pain and degree of nausea, as well as to
      describe any adverse reactions to the medication. Both pain and nausea levels will be
      recorded using 10-point scales. Use of such scales is common in the pain literature, and is
      an emerging tool for evaluation of nausea.1,2 Data collection for analgesia efficacy will
      cease after 60 minutes, but patients will be monitored for at least another 60 minutes to
      maximize safety; patients will be assessed for discharge suitability by treating
      clinicians/nurses in the same fashion as other ED patients who receive opioids.

      Vital signs (respiratory rate, blood pressure, heart rate, pulse oximetry) will be monitored
      for the two hours of the study. Continuous pulse oximetry will be used during the first study
      hour, and q5-minute spot-check pulse oximetry will be used during the second study hour;
      pulse oximetry monitoring will be changed to continuous mode during the second study hour if
      any spot-check reading falls below 98%. Other (non-pulse oximetry) vital signs will be
      monitored q5-minutes during the first study hour, and q15-minutes during the second study
      hour. These vital signs monitoring parameters represent the minimum for study subjects;
      treating clinicians or study staff physicians can increase the frequency of vital signs
      monitoring at their discretion. Any study subject not admitted to the hospital, will be
      discharged under the care of a responsible adult.

      At the conclusion of the data collection period, patients will be asked if they would want to
      receive the same medication in the future. Other than a 24-hour telephone call (made only if
      patients agree), intended to assess for delayed problems such as nausea/vomiting, there will
      be no other study procedures or interventions.
    

Intervention name(s): Fentanyl; Lansoprazole; Oxycodone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fentanyl rapid dissolving tablet 100mcg; lansoprazole 15mg rapidly dissolving tablet; Oxycodone 5/325 mg tablet
Other intervention name(s): Fentora; Prevacid SoluTab; Percocet
Intervention MeSH terms: Fentanyl; Oxycodone; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Emergency Department; acute