Paracetamol Vs Caffeine Vs Codeine in the Management of Post Traumatic Pain in Emergencies

Acute Pain Due to Trauma Clinical Trial

Official title:

Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229965
• Other study ID #: Codeine-Cafeine-Paracetamol
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2022
• Est. completion date: June 27, 2023

Study information

• Verified date: June 2023
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to:

Compare the effect of paracetamol alone against Paracetamol+Codeine association against the association of paracetamol + Cafeine in the treatment of post-traumatic acute pain of the limbs.

Description:

At admission to the emergency department, patients with acute post-traumatic pain will be included, regardless of their initial NRS .These patients will receive the necessary care for their injury (icing, reduction, immobilization, local care, sutures), then went home with a medical prescription and an outpatient appointment .

At discharge and after obtaining their signed consent . All patients included will be randomized according to a numerical randomization table ( assigned in a 1:1:1 ratio) into 3 groups ( As a treatment for their post traumatic pain at discharge for 7 days ) :

• Group 1: Paracetamol group who will receive paracetamol ( 1000 mg) : one pill 3 times a day for 7 days .

• Group 2: Paracetamol-codeine group who will receive an association of 500 mg of Paracetamol and 30 mg of codeine : one pill twice a day for 7 days .

• Group 3: Paracetamol-cafeine group who will receive an association of 500 mg of Paracetamol and 65 mg of cafeine : one pill 3 times a day for 7 days .

For all patients included in the study, demographic and clinical data will be collected by the physician or investigator and recorded on a pre-established form.

The demographic data recorded on each patient's chart were as follows: Age, sex, origin and personal pathological history:

• Hypertension.

• Diabetes.

• Respiratory insufficiency.

• Renal insufficiency.

• Liver failure.

• Allergy.

And a Clinical examination data:

• Pain intensity (NRS).

• Mechanism of trauma and site of injury.

• Other physical examination data: systolic blood pressure (SBP), heart rate (HR) and temperature.

• Nature of traumatic injury.

• Final diagnosis

• Injury Severity Score (ISS).

• NRS at discharge (at rest and on movement).

Patients included will be assessed at Day 1 , Day 2 , Day 3 and Day 7 after discharge from the emergency department by a telephone call. This evaluation will include :

• NRS at rest and during movement

• Secondary use of another analgesic.

• Patient satisfaction assessed by Likert scale, with 3 responses:

• Satisfied

• Moderately satisfied

• Not satisfied

• Side effects: epigastralgia, dizziness, somnolence, headache, nausea and/or vomiting, insomnia, constipation, palpitation, etc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: June 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age :18 years or older

• Patients presented to the emergency department with acute post-traumatic pain and residual pain at rest and/or on movement with a numerical pain rating scale (NRS) > 3/10 on discharge.

• They all signed a written consent form.

Exclusion criteria:

• Self-mutilation

• Severe acute trauma that may require hospitalization

• Open or complicated fracture requiring surgical management

• Regular use of analgesics

• Any known allergy to paracetamol, caffeine or codeine

• Asthma and acute/chronic respiratory insufficiency

• Severe renal insufficiency (creatinine Cl<30 ml/min)

• Pregnant/lactating women

• Hepatic cirrhosis.

• Refusal, incapacity or difficulties to consent or to communicate

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Due to Trauma
• Emergencies

Intervention

Drug:
• Paracetamol
21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period
• Paracetamol Codeine
14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period
• Paracetamol caféine
21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period

Locations

Country	Name	City	State
Tunisia	Nouira Semir	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta Numerical Rating Scale (NRS) ( From 0 to 10 )	Treatment success is defined by the percentage of patients with a reduction in movement NRS at Day 7 discharge (Delta NRS ) = 50% compared with NRS at emergency discharge. ( that mean a better outcome ); Delta NRS ( in movement)=(NRS (at discharge )-NRS (day7))/(NRS (at discharge )) X 100 .	7 days from discharge
Secondary	Appearance of side effects	The appearance of side effects such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness and Digestive hemorrhage.	7 days from discharge
Secondary	Need for another analgesic medication or non-pharmacological analgesic intervention	The patient's need to add another analgesic medication or non-pharmacological analgesic intervention	7 days from discharge
Secondary	Patient satisfaction assessed by Likert's verbal scale at 7 days	patient satisfaction assessed by Likert's verbal scale : with 3 responses: Satisfied; Moderately satisfied; Not satisfied	7 days from discharge