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Efficacy of Paracetamol in Addition to Morphine to Improve Analgesia in the Emergency Department (ParaMoED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03843281
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Bruno Minotti, Cantonal Hospital of St. Gallen

Brief Summary:
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 reduction of adverse drug reactions of morphine.

Condition or disease Intervention/treatment Phase
Analgesia Drug: Paracetamol Drug: Placebo Drug: Morphine Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Paracetamol
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
Drug: Paracetamol
s. above
Other Name: Paracetamol Sintetica

Drug: Morphine
s. above
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
Drug: Placebo
s. above
Other Name: NaCl 0.9%

Drug: Morphine
s. above
Other Name: Morphine Sintetica




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assessment of time interval of pain < 4 on the NRS (after been achieved) [ Time Frame: up to 4 hours ]
  2. Total dose of morphine within the first 4 hours after the first infusion of paracetamol or Placebo. [ Time Frame: up to 4 hours ]
  3. 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 ]

Other Outcome Measures:
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with pain with Pain-score is more or equal than four in a numeric rating scale from zero to ten (i.e. indication for a treatment with morphine)
  • Age over 18
  • Signed informed consent. In case, patient is not able to sign the informed consent due to pain, at least verbal consent has to be provided. After pain relief, written informed consent with data and time has to be obtained

Exclusion Criteria:

  • Analgesia in the past last 6 hours prior to visit at the emergency department
  • Current Analgesia with long-acting/extended-release drugs
  • Current Analgesia with opioids
  • Chronic pain syndrome
  • Contraindication for either paracetamol or morphine
  • Patient's refusal of paracetamol or morphine treatment
  • Pregnancy or Breastfeeding
  • GCS < 13
  • SpO2 < 90% with a maximum of 4 L/Min O2
  • Systolic Blood Pressure < 90 mmHg
  • "Fast Track"/Notfallpraxis patients

Information from the National Library of Medicine

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


Locations
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Switzerland
Kantonsspital St.Gallen Recruiting
Sankt Gallen, Switzerland, 9007
Contact: Bruno Minotti, MD    +41714943603    bruno.minotti@kssg.ch   
Sponsors and Collaborators
Bruno Minotti

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Responsible Party: Bruno Minotti, Sponsor-Investigator, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT03843281    
Other Study ID Numbers: CTU17.014
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bruno Minotti, Cantonal Hospital of St. Gallen:
Paracetamol
Morphine
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Acetaminophen
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics