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Paracetamol and its Influence on the Opioid Requirement in Sufficient Pain Management in the ED


- candidate number28443
- NTR NumberNTR6958
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jan-2018
- Secondary IDsW18_015. METC, AMC, Amsterdam 
- Public TitleParacetamol and its Influence on the Opioid Requirement in Sufficient Pain Management in the ED
- Scientific TitleParacetamol and its Influence on the Opioid Requirement in Sufficient Pain Management in the ED
- ACRONYM
- hypothesisThe use of paracetamol reduces total opioid requirement in the ED and during the first 24 hours.
- Healt Condition(s) or Problem(s) studiedOpioids , Pain, Paracetamol
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
- patients 18 years or older presenting to the ED in the AMC
- an NRS of 4 or higher during presentation
- patients having received an opioid prehospitally (usually in the ambulance) or in the ED
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- hepatic dysfunction
- not capable of reporting their NRS during presentation
- chronic use of analgesics
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 22-jan-2018
- planned closingdate4-mei-2018
- Target number of participants168
- Interventions-
- Primary outcomeThe main study endpoint is the opioid requirement in Morphine Equivalent Units (MEU) between individual subjects who received additional paracetamol and those who did not.
- Secondary outcomeSecondary outcome is the NRS measured an hour after administration of the opioid and at discharge, between individual subjects who received additional paracetamol at the ED and those who did not.
- Timepoints-
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.L. Ridderikhof
- CONTACT for SCIENTIFIC QUERIES M.L. Ridderikhof
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryRationale:
In 2013 about 1.8 million patients visited an ED in the Netherlands, of whom approximately 30.000 attended the AMC. About 50-79% of all patients in the ED complained about pain, and in approximately 40% of these patients, pain was not treated properly.
Of all therapeutically used drugs, opioid analgesics are most frequently associated with adverse drug events. Combining drugs with different mechanisms of action may have an additive or synergistic effect and may lead to a reduction in adverse events. Adjacent paracetamol showed a decrease of approximately 20 to 25% in opioid requirements, postoperatively.
- Main changes (audit trail)
- RECORD17-jan-2018 - 27-jan-2018


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