Back to results

A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain

Primary Purpose

Postoperative Pain

Status

Terminated

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Intravenous ibuprofen

Saline solution

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men or women between 18 and 80 years old.
Being scheduled for elective single surgical site orthopaedic surgery (hip or knee joint replacement, corsed ligaments, column or shoulder surgery), or abdominal surgery (inguinal hernia, cholecystectomy, eventration or hiatus hernia)
Being scheduled for general anaesthesia or regional anesthesia without regional analgesia after surgery.
Having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (PCA).
Expected to stay at the hospital for at least 24 h.
Providing written informed consent for participating in this study.

Exclusion Criteria:

Use of NSAID within 12 hours prior to the first planned dose.
Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or aspirin.
Anaemia (haemoglobin <10 g/dl) and/or history or evidence of asthma or heart failure.
History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or aspirin related products, NSAID or COX-2 inhibitors.
Pregnant or nursing.
Weight less than 40 kg.
History of severe head trauma that required hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion.
History of congenital bleeding diathesis or any active clinically significant bleeding or underlying platelet dysfunction.
Gastrointestinal bleeding that required medical intervention.
Platelet count less than 80.000 determined within the 28 days prior to surgery.
Pre-existing dependence on narcotics or receiving chronic treatment with opioids.
Severe renal failure (calculated creatinine clearance < 60 ml/min).
Liver failure, ALAT or ASAT >3 times upper limit of normality, or bilirubin >2 g/dl.
Diagnosed of Bowel Inflammatory Disease.
Not able to understand the requirements of the study, or to abide by the study restrictions or to return for the required assessments.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

800 mg intravenous ibuprofen

200 ml of saline solution

Arm Description

Treatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours, infused over 15 minutes.

Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours, infused over 15 min.

Outcomes

Primary Outcome Measures

Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo

The primary efficacy endpoint will be the reduction in total morphine use in the first 24 hours post- surgery as compared to placebo.

Secondary Outcome Measures

Secondary efficacy endpoints

- Consumption of morphine in the first 48 h (and 72) hours post- surgery.

Secondary efficacy endpoints

- Pain intensity at rest and with movement measured with the eleven points visual analogue scale (VAS), at 1 and 3 hours and every 6 hours thereafter up to hour 24 h, and then every 8 h up to 6 hour after the last ibuprofen dose.

Secondary efficacy endpoints

- Ramsay-Hunt sedation scale.

Secondary efficacy endpoints

- Time to first subsequent narcotic analgesia (or time to treatment failure).

Secondary efficacy endpoints

- Number of doses of morphine and number of attempts of dosing at PCA

Secondary tolerability and safety endpoints

- Report of adverse events (AEs) during the study

Secondary tolerability and safety endpoints

- Local reactions due to IV infusion (pain, erythema, phlebitis)

Secondary tolerability and safety endpoints

- Vital signs (heart rate, blood pressure, temperature) at 1, 3, 6 hour after the initial dose and every 8 hours thereafter.

Secondary tolerability and safety endpoints

- Routine laboratory tests (chemistry, haematology and coagulation) at baseline and within 24 hours after the last dose.

Full Information

NCT ID

NCT02254525

First Posted

September 25, 2014

Last Updated

October 1, 2014

Sponsor

Biomendi S.A.U.

Collaborators

Pivotal S.L.

1. Study Identification

Unique Protocol Identification Number

NCT02254525

Brief Title

A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain

Official Title

A Multicenter, Randomized, Double-blind, and Parallel Groups, Placebo-controlled Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Terminated

Why Stopped

Sample not reached in traumathology arm

Study Start Date

May 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biomendi S.A.U.

Collaborators

Pivotal S.L.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain and evaluate its tolerability and safety profile.

Detailed Description

This is a phase III, national, multicenter, randomized, double-blind, parallel groups, and placebo-controlled. Patients will be randomized to receive either ibuprofen or placebo. Stratified randomization will be used to assign eligible patients to a stratum according to type of surgery and centre. Randomization sequence will be generated in the coordinating centre. Blinding of the patient and study personnel evaluating response will be warranted by adequate drug labelling. All patients will receive morphine administered by patient controlled analgesia (PCA) following a similar schedule in all centres: 1 mg bolus dose with a close time of 5 min and a maximum of 10 mg in an hour and a maximum of 30 mg in 4 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

231 (Actual)

8. Arms, Groups, and Interventions

Arm Title

800 mg intravenous ibuprofen

Arm Type

Experimental

Arm Description

Treatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours, infused over 15 minutes.

Arm Title

200 ml of saline solution

Arm Type

Placebo Comparator

Arm Description

Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours, infused over 15 min.

Intervention Type

Drug

Intervention Name(s)

Intravenous ibuprofen

Other Intervention Name(s)

IV ibuprofen

Intervention Description

Treatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours up to 72 hours after the first dose. All patients will receive morphine administered by patient controlled analgesia (PCA). Investigation treatment will be administered every 6 hours until 24 h in abdominal surgery, 48 h in hip surgery and 72 h in knee surgery.

Intervention Type

Drug

Intervention Name(s)

Saline solution

Other Intervention Name(s)

Placebo

Intervention Description

Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours up to 72 hours after the first dose. All patients will receive morphine administered by patient controlled analgesia (PCA). Investigation treatment will be administered every 6 hours until 24 h in abdominal surgery, 48 h in hip surgery and 72 h in knee surgery.

Primary Outcome Measure Information:

Title

Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo

Description

The primary efficacy endpoint will be the reduction in total morphine use in the first 24 hours post- surgery as compared to placebo.

Time Frame

First 24 hours post- surgery

Secondary Outcome Measure Information:

Title

Secondary efficacy endpoints

Description

- Consumption of morphine in the first 48 h (and 72) hours post- surgery.

Time Frame