Evaluation of two different strategies for pain management in patients undergoing ablation therapy for cardiac arrhythmias / Utvärdering av två oloika strategier att smärtbehandla patienter som genomgår ablationsbehandling mot hjärtrytmrubbningar i hjärtat

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Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Product Name: morphine Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: MORPHINE CAS Number: 57272 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Product Name: diazepam Pharmaceutical Form: Emulsion for injection INN or Proposed INN: DIAZEPAM CAS Number: 439145 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ Product Name: alfentanil Pharmaceutical Form: Solution for injection INN or Proposed INN: ALFENTANIL CAS Number: 71195589 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Product Name: Midazolam Pharmaceutical Form: Solution for injection INN or Proposed INN: MIDAZOLAM CAS Number: 59467708 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ CONDITION: Patients undergoing catheter ablation due to arrhythmias. ; MedDRA version: 8.1 Level: LLT Classification code 10016566 Term: Fibrillation atrial PRIMARY OUTCOME: Main Objective: To investigate if a strategy with premedication and iterated doses of analgesics and sedative compared with drugs on demand are preferred and better tolerated by patients undergoing catheter ablation. Primary end point(s): Patients experienced pain. Secondary Objective: INCLUSION CRITERIA: Patients undergoing catheter ablation for atrial fibrillation or atrial fibrillation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years)
Epistemonikos ID: ca63c662cbb75b8a0cd26b4ec23b2a1ec27f7bf0
First added on: Aug 21, 2024