The research will be conducted in patients that need short painfull treatment in the emergency department and with an indication for PSA. These treatments include: repositioning of fractures, repositioning of luxation, abcess incision and drainage, wound care, chest drain, electrical cardioversion. We want to find out if remifentanil is a usefull medication for PSA in the emergency department and is the recovery time shorter compared with the frequently used combination fentanyl / propofol.
Conditions
Interventions
Trade Name: Ultiva (remifentanil)
Product Name: ultiva
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
Trade Name: Diprivan (propofol)
Product Name: Diprivan
Pharmace
Sponsors
Albert Schweitzer hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the patients who need procedural sedation and analgesia (PSA) at the emergency department or the observatorium of the Albert Schweitzer hospital location Dordwijk in Dordrecht, age 18 years and older, classified as ASA I en II. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Age under 18 years, hemodynamic and/or respiratory instable, classified as ASA III, IV and V, suspicion of elevated intra-cranial pressure, pregnancy, use of opiates at home, opiates administered before PSA procedure started (in the ambulance, on arrival at the emergency department), intoxication, allergy for fentanyl propofol remifentanil soy or chicken proteins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Answering the following question. Is remifentanil a usefull medication for procedural sedation and analgesia (PSA) in the emergency department and is the recovery time shorter compared to the frequently used combination propofol / fentanyl?;Secondary Objective: Answering the following questions. 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)? 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? Is the length of stay shortened with the use of remifentanil in relation to the use of fentanyl / propofol? Is the specialist satisfied about the treatment given during the procedure? How much is the pain experienced by the patient during the procedure? Is the patient satisfied after the treatment?;Primary end point(s): The recovery time. (time between last dose PSA medication and full recovery of the patient).;Timepoint(s) of evaluation of this end point: After inclusion of 6o patients in this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adverse effects, complications. - Succesfull interventions. - Satisfaction of the specialist about performing the intervention. - Adequate analgesia during procedure. - Satisfaction patient.;Timepoint(s) of evaluation of this end point: From 5 minutes before the procedure, the vital signs are checked every 5 minutes. Immediately after the procedure, the intervention is evaluated with the doctors involved and the patient. Also, the following information is listed on the registartieformulier:The medication and total dosage of analgesic, sedative, concomitant medications, antidote, other medications administered , additional O2 need, deepest Ramsay sedation score, occurrence of incidents / complication and various times (time start PSA, time start surgery, surgery end time, date last gift PSA medication, time patient fully recovers from PSA, patient discharge time). | — |
Countries
Netherlands
Contacts
Public ContactMartijn van Hooft
Albert Schweitzer hospital
Outcome results
None listed