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Effect of Rectal Midazolam on Pain, Stress, and Cooperation of Patient during Urodynamic Test in Women: A Randomized Clinical Trial
Abstract
Purpose: The urodynamic study is an invasive test, and causes pain and stress in the patient. We have investigated the effect of rectal midazolam sedation on the pain, stress, and cooperation of women performing urodynamic study.
Materials and Methods: At the present randomized clinical trial (RCT) from January to July of 2021 a total of 84 women were prospectively randomized to undergo urodynamic study with or without sedation. The primary outcome of interest was experienced pain during urodynamic study. In the intervention group, after monitoring baseline vital signs (heart rate, blood pressure, O2 saturation), sedation was done with rectal midazolam at a dose of 0.3 mg/kg (maximum 15 mg). Completing the procedure, after recovery from sedation patients were asked to fill a self-assessed visual analog pain scale (VAS, 0-10), 5-point visual stress scale (1-5) and, patient collaboration level during urodynamic study was evaluated by nurse with a researcher-made tool (0-3). In the control group test was performed in routine practice with no sedation. Baseline vital signs measured pre and intra-procedural time, as well as their experienced pain, stress, and cooperation levels were recorded.
Results: 84 female cases were evaluated. In terms of comparison of changes in pre and intra-test physiologic parameters, results showed that there were no significant differences between the two groups for all physiologic parameters: SBP, DBP, PR, SpO2. Analysis of the pain score showed that it was lower in the intervention group, and there was a significant difference in pain score between the two groups (P =.024). While the stress and corporation scores were not reported statistically significant (P=.388 and P=.955, respectively).
Conclusion: Sedation with rectal midazolam in adult women before UDS is safe and effective in reducing pain but is not effective in reducing stress and increasing cooperation. The amount of pain based on the visual analog pain scale is mild and although this method is safe, its use routinely is not recommended.
Keywords: Sedation, midazolam, urodynamic study, pain management
... Previous studies investigating adjuvant medication to reduce UDS-associated pain revealed similar results. Saberi et al [21] demonstrated that use of rectal midazolam for women undergoing UDS was associated with a significant decrease in pain, although there was no change in patient stress or collaboration with the operator, in com-parison to placebo. Herd et al [2] reported that oral midazolam was significantly associated with lower stress in children undergoing cystourethrography imaging without compromising detection or grading of vesicoureteral reflux. ...
Background and objective
A urodynamic study (UDS) is a routine clinic procedure that can cause significant discomfort for certain patients, with no satisfactory analgesic alternatives currently available. Our aim was to evaluate the effectiveness of low-dose self-adjusted nitrous oxide (SANO), titrated to the patient’s desired effect, on standard metrics for bladder function and on patient-reported pain and anxiety.
Methods
We conducted a single-institution, double-blind, randomized crossover trial in adults undergoing UDS. Each patient underwent two consecutive UDS runs, randomized to receive oxygen during the first run followed by SANO during the second run, or vice versa. UDS outcomes (capacity, detrusor strength, residual volume) and patient subjective outcomes (Visual Analog Scale for pain and anxiety, operator assessment of verbal feedback) were compared between the two runs. Secondary analyses were performed to compare outcomes during the first UDS run and adjust for treatment order. A paired Wilcoxon signed rank-sum test and McNemar’s χ² test were used to compare continuous and categorical variables, respectively. Adverse events were recorded.
Key findings and limitations
Nineteen patients were randomized (10 to oxygen for the first run, 9 to SANO for the first run). UDS outcomes did not differ between the two arms. Patients reported significantly less pain during the SANO run than during the oxygen run (p = 0.046). Verbal feedback was significantly better with SANO (p = 0.001). Most patients (15/19, 79%) stated that they would prefer to receive SANO during future UDS. There were no significant complications.
Conclusions and clinical implications
SANO oxide is a safe and effective means of preserving standard adult UDS metrics while significantly reducing patient-reported pain.
Patient summary
Urodynamic tests (UDS) for evaluation of lower urinary tract symptoms can cause discomfort and pain. Our study shows that nitrous oxide gas self-adjusted by patients had no effect on UDS test outcomes or on verbal feedback during the procedure, and reduced discomfort and pain in comparison to oxygen. Nitrous oxide may an attractive option for patients who are reluctant to undergo UDS.
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