Clinical trial · Interventional
Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)
Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study
NCT02439034CI-TRIAL-00105563KETOCOLcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The results of the study will permit to set up a standardized and validated procedure of pain management authorizing medical and paramedical staff of brachytherapy department to handle pain and in this way to improve the quality of life of the patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Upper Aerodigestive Tract Neoplasms | — | UNRESOLVED | — |
| Uterine Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketoprofen | Drug | — | UNRESOLVED |
| Paracetamol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Paracetamol
- interventionNames
- Drug: Paracetamol
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Paracetamol + Ketoprofen
- interventionNames
- Drug: Paracetamol
- Drug: Ketoprofen
Primary outcomes (1)
- measure
- Level of immediate post-operative pain
- timeFrame
- Day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with a uterine cervical cancer or an upper aero-digestive tract cancer * Age ≥ 18 years and ≤ 75 years * Patient who are eligible for brachytherapy treatment associated with or without hospital stay * With operative procedure under general anesthesia to set up the material needed for brachytherapy * Performance status ≤ 2 * Creatinine Clearance ≥ 60 ml/min using Cockcroft equation * No coagulation disorder or anticoagulation therapy at curative dose * Registered with a social security system * Patient having dated and signed an informed consent form before initiation of any study procedures Exclusion Criteria: * Respiratory pathology (SpO2\< 70 %) * Severe undernutrition * Previous hypersensitivity reactions such as bronchospasm, asthma, rhinitis, hives or other allergic reaction to ketoprofen, to acetylsalicylic acid, or other NSAIDs * Previous hemorrhage or gastrointestinal perforation during a previous treatment with NSAID * Gastrointestinal hemorrhage , cerebrovascular hemorrhage or other evolutive hemorrhage * Evolutive peptic ulcer, previous peptic ulcer or recurring hemorrhage (2 or more distinct episodes of hemorrhage or ulcer objectified) * Liver insufficiency * Severe renal insufficiency * Severe heart failure * Treatment with another NSAID, including selective cyclooxygenase-2 inhibitors * Intolerance or hypersensitivity to one of the treatments or excipients * Inability to swallow * Pregnant or breastfeeding woman * Patient under tutorship or guardianship
References
Publications (0)
Data not yet available
No reference posted for this study.