Remifentanil use for procedural sedation and analgesia in the emergency department

An important task of the emergency physician is adequate pain control. Use can
be made of Procedural Sedation and Analgesia (PSA) for short-term very painful
procedures. This allows a skilled doctor to give the patiënt a level of
sedation that makes implementation of the specific procedure possible without
being uncomfortable for the patient. Often,used medication for PSA are
fentanyl, propofol (Diprivan).

Remifentanil (Ultiva) is a selective *-opioid agonist with a rapid onset (1-2
minutes) and a very short duration (effective half-life 3 to 10 minutes). It is
currently used mainly as an analgesic during induction and / or maintenance of
general anesthesia and as analgesia in mechanically ventilated intensive care
patients 18 years and older.

The strong analgesic effect, with a rapid onset and a very short duration
suggests that remifentanil is a useful medication for procedural sedation in
Emergency Medicine. A short recovery time is better patient care because the
duration of posibble side effects is shorter and the patient may be discharged
earlier. Also important is that the emergency department is a very busy
department, therefore it is important to be efficient with the available space
and the use of existing staff. When the recovery time of the patient after PSA
is shorter the patient is not only discharged earlier but this also means that
the nurse responsible for monitoring and the space used are available sooner
for another patient.

Answering the following questions:
1. Main question: Is remifentanil a usefull medication for PSA in the emergency
department?
2. What is the recovery time of the patient when using fentanyl / propofol /
remifentanil (time between last gift PSA medication and full recovery of
the patient)?
3. Is there a difference in the occurrence of adverse effects / complications
such as desaturation / apnea / drop in blood pressure / nausea /
vomiting compared to the use of fentanyl / propofol?
4. Is the length of stay shortened with the use of remifentanil in relation to
the use of fentanyl / propofol?
5. Is the specialist satisfied about the treatment given during the procedure?
6. How much is the pain experienced by the patient during the procedure?
7. Is the patient satisfied after the treatment?

Prospective randomized clinical study design. The study is not blinded. The
patient that needs PSA will be classified (after informed consent, present
inclusion criteria, without exclusion criteria) after randomization in one of
the following groups.

1. Fentanyl / propofol group
2. Remifentanil-TCI * / propofol group
3. Remifentanil-TCI group *
* Target Controlled Infusion

Before starting the procedure, the following information will be noted on the
registration form.
General: patient study number, date procedure, name and function sedative
doctor, name and title doctor performing the ttraetment, indication procedure.
Patient data: age, gender, height (cm), weight (kg), relevant history, relevant
medications, allergies, ASA classification, time last meal solid food / milk,
time last meal clear liquid.
Vital signs: heart rate, noninvasive blood pressure, respiratory rate,
saturation

During the procedure
During PSA the heart rate, saturation, respiratory rate and ETCO2 is monitored
continuously and the non-invasive blood pressure is measured every 5 minutes.
This is noted on the registration form, time 0 (start time) is the time at
which th administration of the PSA medication started(fentanyl / propofol /
remifentanil) and time 5, 10, 15, 20 etc are the following minutes when the
vital parameters are noted on the registration form.

After the procedure, the following information is noted on the registration
form.
Medication and total dose: given analgesic, sedative, co-medication, antidote,
other medications administered.
Extra O2 requirement: no, nasal cannula 2-4 L, 15 liters non rebreathing mask,
laryngeal mask, intubation, otherwise.
Deepest Ramsay sedation score.
Have there been incidents/complications: hospitalization due to PSA,
aspiration, agitation, apnea longer than 20 seconds, saturation below 90% for
more than 60 seconds, systolic blood pressure less than 90 mmHg, heart rate
slower than 50/min, nausea, vomiting, dizziness , other.
Performed intervention: stimulation, extra O2, airway maneuvers, ventilation,
intubation, medication
Times: PSA start time, start time intervention, end time intervention, time
last gift PSA medication (fentanyl / propofol / remifentanil by TCI), time
patient fully recovers from PSA, patient discharge time.

After the procedure, the patient is still observed and vital signs: heart rate,
noninvasive blood pressure, respiratory rate and saturation are noted on the
registration form. Patient may be discharged when there is an adequate level of
consciousness, vital signs are stable, patient is able to drink and is not
nauseous.
The following details are noted on the registration form.
Is the original interventione successfull.
How was the original intervention performed: easy, normal or hard.
Is the doctor who performed the original intervention satisfied with the
sedation and analgesia.
Is the patient satisfied, 0-10 scale (0 not satisfied at all and 10 completely
satisfied).
What is the pain score during PSA, 0-10 scale (0 = no pain, 5 = moderate pain
and 10 is worst pain imaginable).
Is there amnesia.
Time when patient is fully recovered, time of discharged

There are three groups in which different PSA medication is administered

One group gets fentanyl and propofol
One group gets remifentanil TCI pump (Target Controlled Infusion (TCI) with an
approved infusion pump, which is equipped with the Minto pharmacokinetic model
with covariates for age and lean body mass) and propofol.
One group will get only remifentanil, with a TCI pump (Target Controlled
Infusion (TCI) with an approved infusion pump, which is equipped with the Minto
pharmacokinetic model with covariates for age and lean body mass).

PSA is a common treatment given in the emergency department. The use of
remifentanil with TCI pump gives no risks other than the currently used
medication when PSA is given such as fentanyl and propofol. We expect no
increased risk of complications in the study population. Since the duration of
the study is limited to the emergency room visit of the patient, the burden for
the patient are minimal.