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

Primary Purpose

Acute Pain Due to Trauma

Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Paracetamol
Paracetamol Codeine
Paracetamol caféine
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain Due to Trauma focused on measuring acute pain, trauma, paracetamol, codeine, cafeine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 years or older
  • acute (<24 hours) post traumatic pain of the extremity and requiring analgesic treatment upon discharge for pain with intensity >3 on a visual numeric scale

Exclusion criteria:

  • open fracture head, abdominal, thoracic or polytrauma.
  • Need for hospitalization, regular use of paracetamol and NSAIDs during the two weeks before admission to ED history of allergy or hypersensitivity to either paracetamol or Codeine or cafeine
  • acute /history of GI hemorrhage and renal insufficiency,
  • an inability to assess pain intensity according to the VNS.
  • Pregnancy
  • heart failure
  • known hepatic cirrhosis
  • known severe renal impairment (Creatinine clearance <30 ml/min)
  • swallowing disorders
  • Refusal, incapacity or difficulties to consent or to communicate

Sites / Locations

  • Nouira Semir

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Paracétamol Group

Paracétamol Codéine Group

Paracétamol Caféine Group

Arm Description

In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracétamol Caféine Group) . In Paracetamol group , the patients will receive a pill containing 1000 mg of paracetamol 3 times a day for 7 days . Paracétamol 1000 mg : 1 pill *3 / day

In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) . In Paracetamol codéine group , the patients will receive a pill containing an association of paracetamol and codéine ( 500mg / 30mg ) 3 times a day for 7 days . -Association of Paracétamol and Codéine ( 500mg / 30 mg) : 1 pill *2 /day

In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) . In Paracetamol caféine group , the patients will receive a pill containing an association of paracetamol and caféine ( 500mg / 65 mg ) 3 times a day for 7 days . -Association of Paracétamol and Caféine ( 500mg / 65 mg) : 1 pill *3 /day

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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.
Need for another analgesic medication or non-pharmacological analgesic intervention
The patient's need to add another analgesic medication or non-pharmacological analgesic intervention
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

Full Information

First Posted
December 8, 2021
Last Updated
June 27, 2023
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT05229965
Brief Title
Paracetamol Vs Caffeine Vs Codeine in the Management of Post Traumatic Pain in Emergencies
Official Title
Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
June 27, 2023 (Actual)
Study Completion Date
June 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain Due to Trauma
Keywords
acute pain, trauma, paracetamol, codeine, cafeine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
study medications consists of a randomly sequence generated numbers. patients and the research associate who collected the outcome data are blinded from the study group
Allocation
Randomized
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paracétamol Group
Arm Type
Active Comparator
Arm Description
In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracétamol Caféine Group) . In Paracetamol group , the patients will receive a pill containing 1000 mg of paracetamol 3 times a day for 7 days . Paracétamol 1000 mg : 1 pill *3 / day
Arm Title
Paracétamol Codéine Group
Arm Type
Active Comparator
Arm Description
In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) . In Paracetamol codéine group , the patients will receive a pill containing an association of paracetamol and codéine ( 500mg / 30mg ) 3 times a day for 7 days . -Association of Paracétamol and Codéine ( 500mg / 30 mg) : 1 pill *2 /day
Arm Title
Paracétamol Caféine Group
Arm Type
Active Comparator
Arm Description
In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) . In Paracetamol caféine group , the patients will receive a pill containing an association of paracetamol and caféine ( 500mg / 65 mg ) 3 times a day for 7 days . -Association of Paracétamol and Caféine ( 500mg / 65 mg) : 1 pill *3 /day
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
1000mg
Intervention Description
21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period
Intervention Type
Drug
Intervention Name(s)
Paracetamol Codeine
Other Intervention Name(s)
500mg/ 30mg
Intervention Description
14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period
Intervention Type
Drug
Intervention Name(s)
Paracetamol caféine
Other Intervention Name(s)
500mg/ 65mg
Intervention Description
21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period
Primary Outcome Measure Information:
Title
Delta Numerical Rating Scale (NRS) ( From 0 to 10 )
Description
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 .
Time Frame
7 days from discharge
Secondary Outcome Measure Information:
Title
Appearance of side effects
Description
The appearance of side effects such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness and Digestive hemorrhage.
Time Frame
7 days from discharge
Title
Need for another analgesic medication or non-pharmacological analgesic intervention
Description
The patient's need to add another analgesic medication or non-pharmacological analgesic intervention
Time Frame
7 days from discharge
Title
Patient satisfaction assessed by Likert's verbal scale at 7 days
Description
patient satisfaction assessed by Likert's verbal scale : with 3 responses: Satisfied Moderately satisfied Not satisfied
Time Frame
7 days from discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Semir
Organizational Affiliation
Monastir University Hospital, Monastir, Tunisia, 5000
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nouira Semir
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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