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Procedure-related access site pain multimodal management following percutaneous cardiac intervention: a randomized control trial |
Brogiene L, Urbonaite A, Baksyte G, Macas A |
Pain Research & Management 2022 Jan 24;(6102793):Epub |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
CONTEXT: Approximately 1 in 20 patients undergoing the percutaneous cardiac intervention (PCI) experience severe procedure-related access-site (A-S) pain. The multimodal pain management model (MPM) can reduce the intensity and prevalence of pain and this approach was not investigated in the postprocedural pain management area. To address this, a randomized controlled trial was conducted in Hospital of Lithuanian University of Health Sciences Kauno klinikos in 2018. METHODS: 137 patients who underwent PCI procedure via radial artery were randomly assigned (1 : 1) to the control (CG, n = 68) and intervention (IG, n = 65) groups. IG received MPM (paracetamol, ibuprofen, and the arm physiotherapy), CG received pain medication "as needed." Outcomes were assessed immediately after, 2, 12, 24, and 48 h, 1 week, and 1 and 3 months after PCI. The primary outcome was A-S pain prevalence and pain intensity numeric rating scale (NRS) 0 to 10. RESULTS: Results showed that A-S pain prevalence during the 3-month follow-up period was decreasing. Statistically significant difference between the groups (CG versus IG) was after 24 h (41.2% versus 18.5, p = 0.005), 48 h (30.9% versus 1.5%, p <= 0.001), 1 week (25% versus 10.8%, p = 0.042), 1 month (23.5% versus 7.7%, p = 0.017) after the procedure. The mean of the highest pain intensity was after 2 h (IG-2.17 +/- 2.07; CG-3.53 +/- 2.69) and the lowest 3 months (IG-0.02 +/- 0.12; CG-0.09 +/- 0.45) after the procedure. A-S pain intensity mean scores were statistically significantly higher in CG during the follow-up period (Wilks' lambda = 0.84 F (7,125) = 3.37, p = 0.002). CONCLUSION: MPM approach can reduce A-S pain prevalence and pain intensity after PCI. More randomized control studies are needed.
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