|- candidate number||22409|
|- NTR Number||NTR5232|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jul-2015|
|- Secondary IDs||ABR Number 45112 EudraCT number: 2013-003220-36, METC file number: NL45112.101.14 |
|- Public Title||Remifentanil use for sedation and pain managment during a painful treatment at the emergency department.|
|- Scientific Title||Remifentanil use for procedural sedation and analgesia in the emergency department|
|- hypothesis||Remifentanil is a usefull medication for procedural sedation and analgesia (PSA) in the emergency department and the recovery time is shorter compared to the frequently used combination propofol / fentanyl?|
|- Healt Condition(s) or Problem(s) studied||Fentanyl, Pain relief, First Aid|
|- Inclusion criteria||All the patients who need procedural sedation and analgesia 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.|
|- 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, known allergy for fentanyl propofol remifentanil soy or chicken proteins. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||29-dec-2014|
|- planned closingdate||29-dec-2015|
|- Target number of participants||60|
|- Interventions||There are three groups in which different PSA medication is administered.
One group gets fentanyl and propofol which is a often used combination of medication for PSA (this is the active control).First dose fentanyl is 1ug/kg iv. First dose propofol is 0,25 mg/kg iv. The dose is titrated to effect.
One group gets 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) and propofol. The target plasma concentration remifentanil starts with 1 ng/ml and can be titrated to effect till a maximum target plasma concentration of 5 ng/ml. First dose propofol is 0,25 mg/kg iv. The dose is titrated to effect.
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).The target plasma concentration remifentanil starts with 1 ng/ml and can be titrated to effect till a maximum target plasma concentration of 5 ng/ml. |
|- Primary outcome||The recovery time ( time between last dose PSA medication and full recovery of the patient).|
|- Secondary outcome||- Adverse effects, complications.|
- Succesfull interventions.
- Satisfaction of the specialist about performing the intervention.
- Adequate analgesia during procedure.
- Satisfaction patient.
|- Timepoints||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 registration form: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
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||
|- CONTACT for SCIENTIFIC QUERIES||
|- Sponsor/Initiator ||Albert Schweitzer Ziekenhuis |
(Source(s) of Monetary or Material Support)
|Albert Schweitzer Ziekenhuis, Dordrecht |
|- Brief summary||We would like to know if remifentanil is a useful medication for PSA in the often busy emergency department (ED) and if the recovery time and time till discharge from the ED is shorter compared with the often used combination of fentanyl and propofol.
Prospective randomized not blinded clinical study design. The patient is assigned to one of the three groups: |
1 Fentanyl / propofol group
2 Remifentanil-TCI * / propofol group
3 Remifentanil-TCI group *
* Target Controlled Infusion
Primary outcome: recovery time
Secondary outcome: adverse effects/ complications, successful intervention, satisfaction of the specialist about
performing the intervention, adequate analgesia during procedure, satisfaction patient.
We expect that remifentanil will be useful medication for PSA at the ED with a shorter recovery time and faster discharge of the patient from the ED compared with the frequently used combination propofol / fentanyl.
|- Main changes (audit trail)|
|- RECORD||3-jul-2015 - 11-aug-2015|