Randomized controlled trial of belladonna and opiate suppository during intravesical onabotulinum toxin A injection.

BACKGROUND: Intravesical injection with onabotulinum toxin A injection can be performed in-office under local anesthesia. Rectally administered pain medication presents a potentially feasible and previously uninvestigated adjunct to office-based anesthesia protocols. OBJECTIVE: The primary aim of this study was to determine whether adding a belladonna and opiate suppository to standard lidocaine instillation resulted in reduction of bladder injection pain during onabotulinum toxin A injection procedure. STUDY DESIGN: This was a prospective, randomized, double-blind, placebo-controlled study of patients undergoing onabotulinum toxin A bladder injection at a single clinic. Patients age ≥18 years, who met clinical criteria for invasive treatment of refractory urinary symptoms, had previously documented postvoid residual volumes <150 mL, and elected for in-office intravesical onabotulinum toxin A injection were eligible to participate. Participants were randomized by computer-generated block randomization to receive a belladonna and opiate (belladonna alkaloid with morphine 16.2/7.5 mg) or placebo suppository. Suppositories were placed immediately prior to lidocaine-based anesthesia, which all participants received. All participants underwent a standardized injection procedure using the same rigid cystoscope, needle type, and injection pattern (20 injections total). A 0-10 numeric rating scale was used to assess pain intensity before anesthesia and suppository, 40 minutes after administration of anesthesia and suppository, after first 10 bladder injections, and immediately after completion of 20 injections. Pain increase during procedure was calculated using the difference between score 40 minutes after administration of anesthesia and suppository and score after first 10 bladder injections. Postvoid residual were measured immediately postprocedure and 2 weeks later. Patient satisfaction with pain control was measured using a Likert scale. Our primary outcome was change in pain level from anesthetic baseline to midprocedure (score after first 10 bladder injections to score 40 minutes after administration of anesthesia and suppository). A final sample size of 26 patients was needed to have 80% power (alpha = 0.05) to detect a 50% reduction in bladder injection pain during the procedure as defined by our primary outcome. An intent-to-treat approach was used for all analyses. RESULTS: In all, 26 participants were enrolled and randomized with 13 in each study arm. Participants in the treatment group were slightly older than in the placebo group (P = .05); there were no statistically significant differences in medical comorbidities. Median score after first 10 bladder injections to score 40 minutes after administration of anesthesia and suppository for the placebo group and treatment group was 4 (range 1-10) and 5 (range 0,9), respectively (P = .94). Median scores immediately after completion of 20 injections for the placebo group and treatment group were 3 (range 0-10) and 2 (range 0,8), respectively (P = .29). There were no significant differences in preinjection pain scores reported before anesthesia and suppository and at 40 minutes after administration of anesthesia and suppository. Postprocedure postvoid residual >200 mL was noted in 5 (38%) of the placebo group and 3 (23%) of the treatment group (P = .67). Two-week postprocedure postvoid residual >200 mL was noted in 3 (25%) of the placebo group and 2 (15%) of the treatment group (P = .64) for an overall rate of 20%. Eleven (84%) participants in each group reported being "mostly satisfied" or "very much satisfied" with pain control. CONCLUSION: Belladonna and opiate suppository use did not significantly reduce bladder injection pain, or increase risk of urinary retention immediately postprocedure or 2 weeks later. Satisfaction with pain control among onabotulinum toxin A injection patients is high.

Bimodal dose-dependent effect on autonomic, cardiac control after oral administration of Atropa belladonna.

This single-blind placebo-controlled study was designed to investigate the dose-dependent vagolytic and vagotonic effects after a single oral administration of Atropa belladonna tincture (ABT, 0.1 mg/ml alkaloid concentration, atropine/scopolamine = 20:1). In eight healthy young subjects, heart rate and noninvasive arterial finger blood pressure were recorded simultaneously over 4 h after oral application of four different doses of ABT (day 1: 2 ml, day 2: placebo, day 3: 5 ml, day 4: 1 ml). On each day, 14 20-min sequences under controlled experimental conditions were performed. Among others, mean RR interval (RR), high-frequency spectral power of heart rate variability (HF), and noninvasive baroreflex sensitivity (BRS) were calculated during metronome breathing in supine position. These parameters were robust markers of vagal activity. One hour after 5ml ABT, RR, HF and BRS decreased clearly in six of eight subjects. This effect was interpreted as vagolytic response. After 1 and 2 ml ABT, and after placebo, RR and HF increased markedly. The increase after ABT was much higher than the increase solely due to adaptation after placebo administration, and it could be clearly identified as an augmentation of vagal cardiac activity caused by low-dose ABT. In conclusion, low doses of orally administered ABT can be effectively used to stimulate parasympathetic activity in man. The mode of vagal activation changes between 2 and 5 ml ABT from vagotonic to vagolytic. ABT has no or very little effect on blood pressure control.

Psychosis following use of proprietary antidiarrhoeal medicines.

Anticholinergic psychosis was observed to follow ingestion of proprietary antidiarrhoeal preparations by a 63-year-old woman. Possible abuse or accidental overuse of such medicines in the acutely psychotic patient should always be considered.

Recent advances in sudden infant death syndrome: possible autonomic dysfunction of the airways in infants at risk.

Epidemiological studies of sudden infant death syndrome (SIDS) reveal a progressive increase in the incidence of cases, suggesting that the in utero environment and postneonatal care were less than optimal. Subtle differences in symptoms could indicate that, since birth, the SIDS infants are different from control infants, some having an autonomic dysfunction of the airway controls. These observations could contribute to a better understanding of some of the causes of sudden death in infants and could eventually lead to new therapeutic approaches.

[Prolonged mydriasis caused by Lamaline]. / Mydriase prolongée à la Lamaline.

Atropine derivatives. The presence of atropine derivatives in numerous combined medicines is often ignored or reflected. A case report of prolonged bilateral non reactive mydriasis with "cycloplegia", linked with the utilisation of a therapeutic dose of Lameline suppositories raises the question of individual susceptibility, with particular ocular sensitivity. This urge one not to ignore the presence of these products and to respect the contraindications, even with minute doses.

Nitrous oxide and oral premedication.

Patients frequently require conscious-sedation to achieve anxiety relief in the dental office. There are specific indications, contraindications, advantages, and disadvantages to each sedation modality. Selection of the appropriate anesthetic technique should be individualized for each patient. This paper reviews two important conscious-sedation modalities: oral premedication and nitrous oxide/oxygen inhalation sedation.Pertinent drugs are reviewed and recommendations are made for their use; current researches are presented and new areas for investigation are suggested.