NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management

Acute Pain Due to Trauma Clinical Trial

Official title:

NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222518
• Other study ID #: PAR vs NSAIDs vs Comb in Pain
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: September 2020
• 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 NSAIDs alone against the association of paracetamol + NSAIDs in the treatment of traumatic pain.

Description:

Paracetamol, NSAIDs, or a combination of the two molecules are usually prescribed. Patients even use these medications without a prescription. It is not known, however, whether or not NSAIDs have an additional value relative to paracetamol for the treatment of pain.

All patients were assigned in a 1:1:1 ratio. Randomization of subjects was performed centrally according to a computer-generated random code provided by one of investigators who was not involved in any other part of the trial. The patients included were divided into 3 groups: Paracetamol group who received paracetamol 1000 mg orally every 8th hour for 7 days; NSAID group who received piroxicam 20 mg orally twice a day for 7 days, and Paracetamol-NSAID combination who received both treatments at the same doses for 7 days. All protocol treatments were administered in opaque packets with code number according to the randomization list by an independent nurse who was not involved in monitoring or follow-up of the individuals. Data were collected for each patient, including demographics, medical history, and findings of the clinical examination. Injury Severity Score (ISS) whose values range from 0 to 75 was also assessed. Each patient was re-evaluated on the 3rd and 7th day post-trauma (D7) using a telephone contact by a clinical research associates who was blinded to the details of the study to note the following clinical data: pain VNS, ED readmissions for residual pain, need for other analgesics other than those of the protocol, other treatment modalities the patient might have used (adherence to the treatment prescribed), and side effects. In addition patients were asked about their satisfaction with pain control following ED using five point Likert scale: very dissatisfied, not satisfied, neutral, satisfied and very satisfied and about the degree to which they adhered to medication schedule. The principal investigator who was aware of the allocation was not involved in monitoring or recording of the outcomes until the data collection was completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 NSAIDs,

• contraindication to paracetamol or NSAIDs,

• 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

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Due to Trauma

Intervention

Drug:
• Paracetamol
21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period
• NSAID
14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period
• paracetamol-NSAID
21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period

Locations

Country	Name	City	State
Tunisia	Monastir University Hospital	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	new oral analgesic medications needed rate	oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition	3 days and 7 days
Secondary	the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later	[delta VNS= (VNS D0 - VNS D7 / VNS D0) x 100]	3 and 7 days
Secondary	The appearance of side effects	The appearance of side effects: such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness.; • Digestive hemorrhage.	7 days
Secondary	the rate of ED readmissions for residual pain	ED readmissions for residual pain	3 and 7 days
Secondary	patient satisfaction assessed by Likert's verbal scale.	patient satisfaction assessed by Likert's verbal scale.	3 and 7 days