To investigate if a high loading dose of 2 grams paracetamol has a beneficial effect on pain sensation or has an opioid-sparing effect in patients with pain in the Emergency Department
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
patienten met pijn op de spoedeisende hulp
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Change in NRS-score.
Secondary outcome
Difference in the need for use of other analgetics. (NSAIDS, Opioids, Ketanest)
To examine if there is a change in the amount of side-effects during admission
in the Emergency Department after a high loading dose of Paracetamol has been
given.
Background summary
An adequate and quick analgesic effect is desirable in the Emergency Department
where some patients can be in severe pain. There appears to be an absent
ceiling effect of paracetamol. Also, a high loading dose of 2 grams can be
given safely to healthy adults. Opioids have numerous undesirable side-effects
like respiratory depression and vomiting, resulting in adverse events such as
apnoea or aspiration.
Study objective
To investigate if a high loading dose of 2 grams paracetamol has a beneficial
effect on pain sensation or has an opioid-sparing effect in patients with pain
in the Emergency Department
Study design
a prospective double-blind placebo-controlled study.
Intervention
2 grams of Paracetamol given orally vs 1 gram of paracetamol given orally
Study burden and risks
The risks are negligible.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Age 18 years and older
Presence of acute pain (pain started less than 24 hours ago) with an NRS-score
of >3
Exclusion criteria
- Weight <50kg
- Use of paracetamol in the last 6 hours
- Daily use of paracetamol
- Known pregnancy
- History of liver insufficiency and/or cirrhosis
- Kidney-insufficiency
- Malnutrition
- Alcohol-addicts
- Thoracic pain
- Patients suspect of intracranial hemorrhage
- Patients suspect of pain due to aneurysma or arterial dissection,
- Patients with chronic pain
- Impossibility to use NRS (physical or cognitive impairment)
- Non-Dutch speaking
- No informed consent
- Known allergy to paracetamol
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-002883-23-NL |
| CCMO | NL67739.042.19 |