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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03843281
• Date of registration: 14/02/2019
• Prospective Registration: Yes
• Primary sponsor: Bruno Minotti
• Public title: Efficacy of Paracetamol in Addition to Morphine to Improve Analgesia in the Emergency Department ParaMoED
• Scientific title: Efficacy of Paracetamol in Addition to Morphine to Improve Analgesia in the Emergency Department: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
• Date of first enrolment: May 2, 2019
• Target sample size: 222
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03843281
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Switzerland

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Analgesia

Intervention(s)

Drug: Morphine

Drug: Paracetamol

Drug: Placebo

Primary Outcome(s)

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(s)

Assessment of time interval of pain < 4 on the NRS (after been achieved) [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]

Total dose of morphine within the first 4 hours after the first infusion of paracetamol or Placebo. [Time Frame: up to 4 hours]

Secondary ID(s)

CTU17.014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors