Download FENTANYL Lollipop Study

FENTANYL Lollipop Study STAFF INFORMATION Inclusion Criteria • Pain score of at least 7/10 on triage • Pain secondary to an Acute (<12hrs) traumatic injury in the absence of a medical precipitant and not relating to any pre‐existing condition (e.g. NOT chronic back pain) • Adult patients, Male and Female, 18 to 59 years • ASA I or II only • No prehospital opiate administered, including Codeine based products. • Prior administration of Paracetamol and Ibuprofen does not effect inclusion into the study. • Not currently taking MAOIs or Verapamil • No contraindications to administering Fentanyl, Paracetamol nor Ibuprofen. • Fully orientated and able to understand instructions on how to use device. • Consents to be included in study both at time of inclusion and reaffirms consent >24 hours post admission, when pain free and not under the influence of potent analgesic or hypnotic agents. Definitions: Pain Score:
Use Visual Analogue Scale,
ie. Patient points to their pain on chart and rates on scale of 1 to 10
ASA I:
ASA II:
Patients are considered to be normal and healthy.
Patients may have mild to moderate systemic disease which is well-controlled
and does not limit daily activity. E.g well controlled diabetes, hypertension,
epilepsy, asthma, etc. If they have anything that limits their daily activity, they
are not to be included in this study.
MAOIs: OTM: Monoamine oxidase inhibitors (MAOIs), a class of antidepressant drugs which are virtually completely phased out of practice now. Examplesinclude: Phenelzine (Nardil®) or Isocarboxazid Refers to the Oral Transmucosal route of drug administration What to do next: •
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Administer 1G Paracetamol and 400mg Ibuprofen if not already done in last 6 hours.
Give patient study envelope; ask them to read information sheet and sign consent form.
Nursing Staff to witness and sign consent form
ED doctor to sign consent and Prescribe “Fentanyl 1200mcg OTM”
Collect Fentanyl lollipop and sticker from CD Press.
Place blue “Fentanyl” sticker on the TOP Right hand corner of the front page of ED notes.
Advise patient on the correct use of OTM Fentanyl as per their information sheet. Attach Automated Study Monitor.
Record a full set of observations to include all items on page 8 of the ED notes, letting the
patient show you their pain score on the VAS in their information sheet.
Administer Fentanyl Lollipop
Follow the protocol for recording data.
Recording Data: Time Zero (T-0)
This is the first measurement, immediately prior to administering the Fentanyl Lollipop.
“T-0” to be clearly marked above the time box.
Automated Measurements:
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Time
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Pulse Rate
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Respiratory Rate
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SpO2
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Non-invasive Blood Pressure
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ECG
All above observations will be repeated every 5 minutes, by an automated patient monitor, designated for the
study period for a minimum period of 1 hour.
Nursing Measurements:
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Pain Score stated by patient using VAS and converted to numerical (1-10) score.
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Pupil Size
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GCS
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O2 Delivered
Nursing measurements will be repeated every 5 minutes, whilst the patient is using the OTM fentanyl.
Following removal of the devise, for whatever reason, a minimum of 2 further sets of observations to be made.
Further measurements to be made as per clinical need.
Should the pain score be ≥3 after 20minutes, patients must be re-evaluated by a physician and appropriate
rescue analgesia prescribed and decisions recoded.
Time PAIN CONTROLLED (T-PC)
Is defined, as the time point where the patients pain score is ≤2. This point is recorded above the time box.
The lollipop may or may not be removed from the patient at this point, as per staff discretion. For example a
patient may be about to undergo further painful stimuli and in this case it is prudent for the drug may be retained
for analgesia over this period. All such decisions to be recorded on page 3 of the Emergency Department notes
as per normal practice (Nursing Section).
Time FINISHED (T-F)
Is defined as a time point when the lollipop has been completely consumed regardless of pain controlled or note.
This point is recorded above the time box.
Time REMOVED (T-R)
Is defined as a time point when an unfinished lollipop has been removed by either the patient or staff and
irretrievably discarded. This is NOT a point where a patient simply takes the devise out of their mouth. eg.
Their pain is controlled, for conversation purposes, to consume water or other medications etc.
This point is recorded above the time box and any decisions recorded on page 3 of the Emergency Department
notes (Nursing Section), as per normal legal requirements for discarding controlled drugs.
ie. This may include:
Pain Controlled (T-PC)
Time Finished (T-F)
Over Sedation, Side Effects, Not Tolerated, Staff Concern, etc.
Time Intervention (T-I)
In many cases, patients may have a painful procedure performed, eg. wound dressing, relocation of a dislocation
or reduction of a fracture. This may also include the re-evaluation and administration of additional medications
at the 20 minute period, should the pain score be ≥3. This point is recorded above the time box and in detail in
the medical and nursing notes as per standard practice.