New Protocol in NY: Make your own change by collecting evidence & taking action - Administration and Leadership - @

New Protocol in NY: Make your own change by collecting evidence & taking action



Michael W. Dailey, MD, FACEP | From the July 2008 Issue | Friday, July 25, 2008

Changing a protocol requires significant time and energy. The reason for the change must be clear andevidence-based, and there must be measurable benefits. The 2005 AHA guidelines are an example of the amount of evidence that must be reviewed before a major protocol can be altered. (1) For a grassroots effort to change one protocol, we must review precedent, abstract medical literature and consider practice patterns across similar systems.

Pain-management practices are growing more consistent across the country. In an unpublished 2005 study, 35 states allowedEMS providers to administer opiate analgesia without direct physician contact. InNew York, use of opiate analgesia by ground crews was restricted to online physician orders only. It was employed on less than 1% of patients, and the only agent available was morphine. So the REMO region, six counties around the Capitol Region of Albany, decided to change this.

The initial evaluation

The REMO region is fortunate to have an active group of prehospital providers and physicians providing leadership to ourEMS agencies through the Medical Advisory Committee (MAC). We also have many providers and physicians interested in research and education.

In 2004, as part of an advanced education degree, one paramedic instructor reviewed the use of morphine by our providers, specifically for extremity injuries and burns. Among the things she discovered were delays to administration of pain medication as great as 61 minutes because of failure to secure medical command for authorization to administer morphine. The mean time-to-medication in the study was 27 minutes, with a range of four minutes to 61 minutes. The shortest time-to-treatment was because a physician who had medical command privileges was riding along with the paramedic unit, and the longest was because of communication difficulties.

The average dose of morphine requested by the paramedic was 6.6 mg, and the average dose ordered by the physician was 7.4 mgƒa significant difference. There were no denials of morphine order by any command physician. (2) Because there was no opposition to morphine in this subset of patients, and there seemed to be a significant delay to medication administration when contacting a physician, we recognized the need for a protocol that would allow standing orders for pain medication.

More evidence

It has been well established that prehospital analgesia is a simple and safe endeavor and should be a mainstay of prehospital care. (3) Both basic and advanced providers can have alternatives for safe and effective pain management. But obtaining medical direction for pain management is a time delay to administration, and many prehospital analgesic treatment decisions can be managed with paramedic discretion, comprehensive treatment protocols and standing orders. (4,5) This model has been shown to safely decrease the time fromEMS arrival to administration of prehospital analgesia. (6)

For example, one study we reviewed exhibited a protocol change that decreased time-to-medication by 2.1 minutes, or 11%. However, an increase was not found in total medication administered, number of administrations or proportion of prehospital patients receiving pain medications.

Timely and appropriate pain management is a goal of ourEMS system, and may be one of the most important additions ALS providers can add to patient care. Even hospital care has this focus, with ATLS Version 7 focusing on it. Moreover, national organizations have discussed quantifying pain as the ˙sixthÓ vital sign. (3,7)

Using this information, coupled with additional research and literature review, members of the MAC approached the Department of Health (DOH) Bureaus that oversee changes in regulation. We wrote a conservative protocol that would allow for safe administration of morphine in extremity injuries, burns and other specific situations. (8) Controlled-substance regulations already allowed for standing-order administration of benzodiazepines in seizures, so there was precedent for the use of a controlled substance in the field without direct physician communication.

Bureau of Narcotic Enforcement Director James Giglio said it best: ˙We do not want to stand between you and the care of your patients. ... You worry about patient care and [the regulators] will worry about diversion.Ó

Working with Lee Burns, from the Bureau of EMS (BEMS), we reviewed the current controlled substance accounting and distribution plans for the lead agencies to assure them it would allow the level of security the regulators would require.

With a change of this magnitude, we wanted to be certain we were improving patient care, not just creating a new boondoggle for BEMS. A group of physicians and paramedics submitted a research plan to the IRB atAlbanyMedicalCenter and also applied for a grant from the Prehospital Trauma Life Support Research Foundation to study the protocol change.

We learned that time-to-medication dropped by more than 20%, with most patients getting their first dose of pain medication in fewer than 20 minutes. In patients with burns, pain medication was administered in fewer than 10 minutes afterEMS arrival. There were no complications and no diversions, and the use of pain medications did not drastically increase. This data was presented to the Prehospital Trauma Life Support committee inLas Vegas, as well as to the State Emergency Medical Advisory Committee (SEMAC), to clearly demonstrate the safety and efficacy of our protocol for administration of pain medications.

Fentanyl in the field

Although morphine is an effective medication, it_s not the best analgesic medication for prehospital care. Fentanyl, a synthetic opiate, has many properties that make it a better choice forEMS administration. Fentanyl_s onset of action is quicker, its half-life is briefer and there are fewer side effects than morphine. This makes the medication better for cases of abdominal pain and multi-system trauma. (9)

Multiple papers demonstrate the safety of fentanyl as anEMS analgesic. In 2005, fentanyl was approved for use in 17 states; however, it was not approved for use inNew York. Now, after the successful implementation of the regional pain-management program, the REMO regional MAC approached the DOH for permission to use fentanyl in the prehospital arena. The state agencies developed conservative guidelines for implementation of the medication, and the SEMAC approved the protocol unanimously. (10,11) (Go to view REMO_s pain-management protocol.) Editor_s Note:"Click here to view a pdf of REMO's pain-management protocol."

In December 2007, Colonie EMS became the first ground agency inNew York to administer fentanyl, caring for a patient with severe abdominal pain. The second patient was a police officer who had significant pelvic trauma following a motor vehicle crash. Because of their chief complaints, both patients may not have received pain medications had the only choice been morphine. Although the fentanyl was administered with medical control consultation, the time-to-medication was rapid, and both patients experienced significant pain reduction.


Being a medical director for an agency or a region places the physician in an interesting role, advocating for both their providers and patients while interfacing with hospital physicians and state officials. Improving prehospital care is a partnership between providers and medical direction.

Concerns from paramedics and physicians drove these changes inNew York. Regulators and state officials were willing and interested in following the direction of the people providing care, as long as safety of the narcotic_s use could be ensured. Partnering with regulators allowed us to develop a plan that could satisfy each constituent of the process and ultimately improve patient care in the field. JEMS

Michael W. Dailey, MD, FACEP, is an assistant pro- fessor of emergency medicine and director of prehospital care and education at theAlbanyMedicalCollege inAlbany,N.Y. He has been involved in EMS for more than 25 years, with experience in volunteer suburban EMS, rural volunteer fire service, urban municipal EMS and helicopterEMS. He_s theEMS medical director for the Hudson Mohawk Region, the six counties surrounding the state capital. Contact him

Acknowledgement: The author thanks Assistant Chief Paul Fink of the Town ofColonie EMS for assistance with the photograph.


  1. 2005 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care.ÓCirculation. 112(24):Supplement, 2005.
  2. Kufs D: ˙Pain management in the REMO region.Ó 2004. Unpublished.
  3. Alonso-Sierra HM, Wesley K: ˙For the NAEMSP standards clinical practice committee: Prehospital pain management [position paper].ÓPrehospital Emergency Care. 7:482Ï488, 2003.
  4. Holliman CJ, Wuerz RC, Vazquez-de Miguel G, et al: ˙Comparison of interventions in prehospital care by standing orders versus interventions ordered by direct medical command.ÓPrehospital Disaster Medicine. 9(4):202Ï209, 1994.
  5. Bledsoe B: ˙Adios, rampart: Give medical control the boot.ÓJEMS. 27(5):168, 2002.
  6. Fullerton-Gleason L, Crandall C, Sklar DP: ˙Prehospital administration of morphine for isolated extremity injuries: A change in protocol reduces time to medication.ÓPrehospital Emergency Care. 6(4):411Ï416, 2002.
  7. AmericanCollegeof Surgeons: Advanced Trauma Life Support for Doctors, Version 7. 2004.
  8. REMO 2006 Protocols.
  9. Bledsoe B, Braude D, Dailey MW, et al: ˙Simplifying prehospital analgesia.ÓJEMS. 30(7):56Ï63, 2005.
  10. New York State Department of Health: ˙Policy Statement.Ó
  11. REMO 2007 Editor_s Note:"Click here to view a pdf of REMO's pain-management protocol."

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Related Topics: Administration and Leadership, Operations and Protcols, Jems Medical Director Forum

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