Efficacy of Paracetamol in Addition to Morphine to Improve Analgesia in the Emergency Department (ParaMoED)
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|ClinicalTrials.gov Identifier: NCT03843281|
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Analgesia||Drug: Paracetamol Drug: Placebo Drug: Morphine||Phase 4|
Paracetamol (acetaminophen) is widely used around the world for mild to moderate pain in all age groups. Prescription at the emergency department is very common and some studies suggest the use in alternative of Morphine, at least in the renal colic.
Morphine has also a complex analgesic effect due to inhibition of µ Receptors in the central nervous system and in the dorsal horn of the spinal cord. Morphine (like other opioids) is accepted as a cornerstone of acute pain management in the emergency department. However, occurrence of adverse drug reactions is up to 25%, mainly nausea and drowsiness.
The use of paracetamol in addition to morphine showed in a meta-analysis in the post-operative setting an opioid sparing effect of 20% over the first postoperative 24 hours, but did not change the incidence of morphine-related adverse effects in the postoperative period. An additive effect was showed of the two medicaments in another Study measuring the median effective analgesic dose (ED50).
The purpose of this study is to test the additional effect of paracetamol in combination with morphine for analgesia, respectively to test/confirm an opioid sparing effect due to the additional use of Paracetamol, as well as the to reduction of adverse drug reactions of morphine.
The study is a multicenter, randomized, double-blind, placebo-controlled. We randomize patients with pain-score >=4 on a pain Scala of 0-10 Points (numeric rating scale) in two group, one with paracetamol, one with placebo to investigate the (additive) effect of paracetamol in combination with morphine. The treatment team and the patients will be blinded to the administration. The study design is outlined to confirm the result of previous studies who stated a 20% reduction of morphine doses when combined with paracetamol. Study duration for each patient would be 240 min.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Paracetamol in Addition to Morphine to Improve Analgesia in the Emergency Department: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial|
|Actual Study Start Date :||May 2, 2019|
|Estimated Primary Completion Date :||July 15, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Paracetamol 1 g (100 mL) IV + Morphine 0.1 mg/kg IV (repeatable in Doses of 0.05 mg/kg), 100 patients over 4 hours
Other Name: Paracetamol Sintetica
Other Name: Morphine Sintetica
Placebo Comparator: Placebo
Placebo (NaCl 0.9% 100 mL IV) + Morphine 0.1 mg/kg IV (repeatable in Doses of 0.05 mg/kg), 100 patients over 4 hours
Other Name: NaCl 0.9%
Other Name: Morphine Sintetica
- Assessment of the total dose of morphine till pain < 4 on the NRS (0-10) after the first infusion of paracetamol or placebo. [ Time Frame: up to 4 hours ]
- Assessment of time interval of pain < 4 on the NRS (after been achieved) [ Time Frame: up to 4 hours ]
- Total dose of morphine within the first 4 hours after the first infusion of paracetamol or Placebo. [ Time Frame: up to 4 hours ]
- Prevalence of morphine adverse reactions within the first 4 hours after infusion of paracetamol or placebo [ Time Frame: up to 4 hours, respectively in case of serious adverse events up to recovery time of the patient ]
- Maximal Dose of Morphine based on adverse events [ Time Frame: up to 4 hours ]A maximal Dose of opioids has been defined in our daily practice and in several guidelines with a precise number (e.g. 20 mg/4 h). In this trial we will use instead a maximal Dose defined with clinical criteria (GCS < 13, SpO2 < 90% with 4 L/min O2, uncontrolled vomiting). Assessment intended as occurrence of adverse events of the application of a such algorithms will be outcome of interest (not a secondary outcome because absence of a control group)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843281
|Sankt Gallen, Switzerland, 9007|
|Contact: Bruno Minotti, MD +41714943603 firstname.lastname@example.org|