Affiliation:
1. Duke Heart Center Duke University Health System Durham North Carolina USA
2. Department of Psychiatry & Behavioral Sciences Duke University School of Medicine Durham North Carolina USA
3. Department of Medicine, Division of Cardiology Duke University School of Medicine Durham North Carolina USA
4. Department of Medicine, FACC Duke Program for Advanced Coronary Disease, Division of Cardiology Duke University School of Medicine Durham North Carolina USA
5. Department of Medicine, Division of Cardiology, Duke Clinical Research Institute Duke University School of Medicine Durham North Carolina USA
6. Duke School of Nursing Duke University Durham North Carolina USA
Abstract
AbstractBackgroundInvasive cardiac catheterization (CC) temporarily increases pain, discomfort, and anxiety. Procedural sedation is deployed to mitigate these symptoms, though practice varies. Research evaluating peri‐procedural patient‐reported outcomes is lacking.Methods and ResultsWe randomized 175 patients undergoing CC to short interval ([SI] group, <6 min) or long interval ([LI] group, ≥6 min) time intervals between initial intravenous sedation and local anesthetic administration. Outcomes included: (1) total pain medication use, (2) patient‐reported and behaviorally assessed pain and (3) patient satisfaction during outpatient CC. Generalized linear mixed effect models were used to evaluate the impact of treatment time interval on total medication utilization, pain, and satisfaction. Among enrollees the mean age was 62 (standard deviation [SD] = 13.4), a majority were male (66%), white (74%), and overweight (mean body mass index = 28.5 [SD = 5.6]). Total pain medication use did not vary between treatment groups (p = 0.257), with no difference in total fentanyl (p = 0.288) or midazolam (p = 0.292). Post‐treatment pain levels and nurse‐observed pain were not statistically significant between groups (p = 0.324 & p = 0.656, respectively. No significant differences with satisfaction with sedation were found between the groups (p = 0.95) Patient‐reported pain, satisfaction and nurse‐observed measures of pain did not differ, after adjustment for demographic and procedural factors. Analyses of treatment effect modification revealed that postprocedure self‐reported pain levels varied systematically between individuals undergoing percutaneous coronary intervention (PCI) (SI = 2.2 [0.8, 3.6] vs. LI = 0.7 [−0.6, 2.0]) compared with participants not undergoing PCI (SI = 0.4 [−0.8, 1.7] vs. LI = 0.7 [−0.3, 1.6]) (p = 0.043 for interaction).ConclusionNo consistent treatment differences were found for total medication dose, pain, or satisfaction regardless of timing between sedation and local anesthetic. Treatment moderations were seen for patients undergoing PCI. Further investigation of how procedural and individual factors impact the patient experience during CC is needed.
Subject
Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging,General Medicine