Reduce Nonsteroidal Antiinflammatory Drugs Doses for Analgesia After Sternotomy

NCT02180087 | Unknown Phase 2

• 2 other identifiers: CHU-01982013-003878-27
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the management of pain after cardiac surgery is based on the concept of multimodal analgesia: Combined use of non-opioid analgesics associated with morphine intravenous analgesia by a system controlled by the patient (patient-controlled analgesia-PCA). The combination of paracetamol and morphine PCA is very effective on pain at rest, but is limited on pain mobilization and causes the problem of side effects associated with opioid (overdose, sedation, respiratory depression, gastrointestinal intolerance, urinary retention ...) which are contributing factors to increase the length of stay in Intensive Care Unit, an additional cost of care and an increase postoperative morbidity and mortality. Methods that have proved their effectiveness on pain and mobilization used in postoperative cardiac surgery are: anti-inflammatory drugs (NSAIDs) and / or loco-regional analgesia techniques. NSAIDs enhance analgesia produced by PCA Morphine and allow a reduction in morphine consumption, improved postoperative pain, decreased sedation and decreased postoperative morbidity and mortality. Adverse effects of NSAIDs are commensurate with their time and exposure dose. Consequently, NSAIDs, in the absence of against-indications, should always be prescribed and used at the lowest effective dose and for the shortest possible time. Some studies have suggested that lower doses of NSAIDs didn't appear to affect their effectiveness. At present, the investigators have no studies that address the hypothesis from which minimum dose of ketoprofen analgesic effect is obtained. The investigators hypothesis is that lower dose ketoprofen may have efficacy on pain in the postoperative mobilization of cardiac surgery. The investigators want to find, in their study, this "optimal" ketoprofen dose which would be the minimum dose for clinical efficacy demonstrated dose. This optimal dose could reduce the number of adverse effects of NSAIDs, but their study will probably not have enough power to prove it. NSAID use at these low doses, in postoperative cardiac surgery, could be extended to patient populations most at risk or for a duration longer than 48 hours.

Conditions

Cardiac Surgery; Post-operative Pain

Keywords

Cardiac surgery; Post-operative pain; Kétoprofène; Minimum analgesic dose; Morphin consumption; Morphin secondary effects; Patient comfort and satisfaction; Renal fonction

Outcome Measures

Primary Outcomes (1)

• Pain at the mobilization

  Pain at the mobilization of the first 48 hours postoperatively, measured every 4 hours by simple numerical scale or VAS (0: no pain to 10: unbearable pain)

  At the first 48 hours postoperatively

Secondary Outcomes (13)

• Demographic criteria

  at day 1

• Quantity of sufentanil administered intraoperatively

  at day 1

• Pain at rest measured by Visual Analogue Scale

  at day 1

• Total morphine consumption

  from H0 to H0+48 hours

• Blood gas monitoring 3 times a day

  from H0 to H0+48 hours

Study Arms (4)

placebo group

PLACEBO COMPARATOR

Group 1 : Placebo group (P). 0 mg/kg ketoprofen IV every 6 hours for 48 hours (or 0 mg/kg every 24 hours) for 48 hours

Drug: Ketoprofen

ketopofen quarter dose

OTHER

Group 2 : "Ketoprofen quarter dose" (K ¼). 0,125 mg/kg ketoprofen IV every 6 hours (0,5 mg/kg every 24 hours) for 48 hours.

Drug: Ketoprofen

ketoprofen half-dose

OTHER

Group 3 : "Ketoprofen half-dose" (K ½). 0,25 mg/kg ketoprofen IV every 6 hours (1 mg/kg every 24 hours) for 48 hours.

Drug: Ketoprofen

Ketoprofen full dose

OTHER

Group 4 : "Ketoprofen full dose" (KPD). 0,5 mg/kg ketoprofen IV every 6 hours (or 2 mg/kg every 24 hours) for 48 hours

Drug: Ketoprofen

Interventions

Ketoprofen DRUG

Ketoprofen full dose; ketopofen quarter dose; ketoprofen half-dose; placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for a cardiac surgery (Coronary artery bypass graft, valve replacement)
• Age over 18 years
• Weight between 60 and 100 kg

You may not qualify if:

• Age over 75 years
• Renal insufficiency (MDRD \<60 ml / min)
• Hepatic Insufficiency
• Congestive heart failure (EF \<40%)
• Insulin-requiring diabetes
• Preoperative coagulation trouble
• History of peptic ulcer or gastrointestinal bleeding
• Allergy to NSAIDs
• Surgery in emergency, aorta surgery, heart transplantation
• Peptic ulcer scalable, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified)
• Pregnant or lactating women
• Major protected

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• Eljezi V, Biboulet C, Boby H, Schoeffler P, Pereira B, Duale C. The Dose-Dependent Effects of Ketoprofen on Dynamic Pain after Open Heart Surgery. Pain Physician. 2017 Sep;20(6):509-520.

  PMID: 28934782 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Personal Satisfaction

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Vedat ELJEZI

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 2, 2014

Record last verified: 2014-07

Locations

FR (1)