Unilateral electrical stimulation of the heart 7 acupuncture point to prevent emergence agitation in children: A prospective, double-blinded, randomized clinical trial.

BACKGROUND: Emergence agitation (EA) is a frequent phenomenon in children recovering from general anaesthesia and increases the risk of self-injury. Previously, our group reported that stimulating the heart 7 (HT7) acupuncture point bilaterally using two neuromuscular transmission monitoring devices (NTMs) decreased the incidence of EA. However, bilateral stimulation is a barrier to clinical use because two NTMs are needed for one patient. OBJECTIVE: The objective of this study was to examine the efficacy of unilateral electrical stimulation of HT7 using an NTM to prevent EA in children. DESIGN: Prospective, double-blinded, randomized clinical trial. SETTING: Kanagawa Children's Medical Centre, Yokohama, Japan. PATIENTS: One hundred children (ages 18-96 months) with ASA-PS I or II, who were scheduled to undergo inguinal hernia repair or orchiopexy under sevoflurane anaesthesia. INTERVENTION: Patients were randomly assigned to one of the following two groups: (1) HT7 group: unilateral (right side) stimulation of the HT7 acupuncture point using a single-twitch electrical stimulus (1 Hz, 50 mA) throughout the surgery, and (2) control group: electrodes alone were attached to the HT7 point on the right side; an electrical stimulus was not applied. MAIN OUTCOME MEASURES: The primary outcome was the incidence of EA evaluated using the pediatric anaesthesia emergence delirium (PAED) scale. The secondary outcomes were the incidence of EA evaluated using Aono's scale, the severity of EA, PACU stay duration, and postoperative pain. RESULTS: There was no statistical difference between the incidence of EA in the HT7 and the control group (28.0% and 24.0%, respectively; P > 0.99). The risk ratio was 1.17 (95% confidence interval: 0.60-2.27). CONCLUSIONS: We observed that there was no effect of unilateral single-twitch electrical stimulation to the HT7 on the incidence of EA, contrary to the findings with bilateral HT7 stimulation.

Effect of magnesium added to local anesthetics for caudal anesthesia on postoperative pain in pediatric surgical patients: A systematic review and meta-analysis with Trial Sequential Analysis.

BACKGROUND: Magnesium has been investigated as an adjuvant for neuraxial anesthesia, but the effect of caudal magnesium on postoperative pain is inconsistent. The aim of this systematic review and meta-analysis was to evaluate the analgesic effect of caudal magnesium. METHODS: We searched six databases, including trial registration sites. Randomized clinical trials reporting the effect of caudal magnesium on postoperative pain after general anesthesia were eligible. The risk ratio for use of rescue analgesics after surgery was combined using a random-effects model. We also assessed adverse events. The I2 statistic was used to assess heterogeneity. We assessed risk of bias with Cochrane domains. We controlled type I and II errors due to sparse data and repetitive testing with Trial Sequential Analysis. We assessed the quality of evidence with GRADE. RESULTS: Four randomized controlled trials (247 patients) evaluated the need for rescue analgesics. In all four trials, 50 mg of magnesium was administered with caudal ropivacaine. The results suggested that the need for rescue analgesia was reduced significantly by caudal magnesium administration (risk ratio 0.45; 95% confidence interval 0.24-0.86). There was considerable heterogeneity as indicated by an I2 value of 62.5%. The Trial Sequential Analysis-adjusted confidence interval was 0.04-5.55, indicating that further trials are required. The quality of evidence was very low. The rate of adverse events was comparable between treatment groups. CONCLUSION: Caudal magnesium may reduce the need for rescue analgesia after surgery, but further randomized clinical trials with a low risk of bias and a low risk of random errors are necessary to assess the effect of caudal magnesium on postoperative pain and adverse events. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry UMIN000025344.

Electrical stimulation of the heart 7 acupuncture site for preventing emergence agitation in children: A randomised controlled trial.

BACKGROUND: Emergence agitation is common in children recovering from general anaesthesia. The prevention of emergence agitation remains an important challenge in the field of paediatric anaesthesia. OBJECTIVE: We aimed to examine the effectiveness of electrically stimulating the heart 7 (HT7) acupuncture site with a peripheral nerve stimulator (PNS) during surgery, for preventing emergence agitation in paediatric patients recovering from general anaesthesia. DESIGN: A double-blind, randomised, controlled, parallel-group trial. SETTING: Kanagawa Children's Medical Centre, Yokohama, Japan. PATIENTS: One hundred and twenty patients aged 18 to 96 months (American Society of Anesthesiologists physical status I or II) undergoing minor elective surgery under general anaesthesia with sevoflurane. INTERVENTION: Patients were randomly assigned to either undergo bilateral stimulation of HT7 with two PNS devices (1 Hz, 50 mA) during surgery (Group HT7) or a control group that did not undergo electrical stimulation of HT7 during surgery. MAIN OUTCOME MEASURES: The primary outcome was the incidence of emergence agitation evaluated in the postanaesthesia care unit (PACU) using the Paediatric Anaesthesia Emergence Delirium scale. The secondary outcomes were the time from operation completion to tracheal extubation, PACU stay duration and postoperative pain scores. RESULTS: The incidence of emergence agitation was significantly lower in the HT7 group compared with the control group (31.7 vs. 56.7%, respectively; P = 0.010). The risk ratio was 0.56 (95% confidence interval 0.36 to 0.86) and the number needed to treat was 4 (95% confidence interval 3 to 13). There were no statistically significant differences between groups in time from operation completion to tracheal extubation, PACU stay duration or postoperative pain. CONCLUSION: Bilateral electrical stimulation of HT7 using two PNS devices significantly decreases the incidence of emergence agitation. TRIAL REGISTRATION: UMIN Clinical Trial Registry (registry number: UMIN000011704).

Effects of melatonin premedication to prevent emergence agitation after general anaesthesia in children: A systematic review and meta-analysis with trial sequential analysis.

BACKGROUND: Emergence agitation is a common phenomenon in children recovering from general anaesthesia. An emergence agitation reaction increases the risk of injuring the surgical repair, the patient and the caregivers. OBJECTIVE: The objective of this study is to examine the efficacy of melatonin premedication in emergence agitation prevention. DESIGN: A systematic review and meta-analysis of randomised controlled trials (RCTs) with trial sequential analysis (TSA) and meta-regression analysis. DATA SOURCES: We searched MEDLINE, the Cochrane Central Register of Controlled Trials, Embase, Web of Science, clinicaltrials.gov and UMIN Clinical Trials Registry up to 4 April 2014. ELIGIBILITY CRITERIA: RCTs reporting effects of melatonin on the incidence of emergence agitation in children who underwent general anaesthesia were included. RESULTS: Four studies (358 participants) were analysed. A conventional random-effects meta-analysis showed that compared with placebo, melatonin premedication may be effective in emergence agitation prevention [risk ratio 0.31, 95% confidence interval (CI) 0.16 to 0.60; I2 = 0%]. However, TSA corrected the 95% CI to 0.07 to 1.47 and showed that 22.5% of the required information size (RIS) was achieved. The effect of melatonin compared with that of midazolam was not statistically significant (risk ratio 0.48, 95% CI 0.15 to 1.52) with significant heterogeneity (I2 = 36.8%). TSA-adjusted 95% CI could not be calculated because of the small information size (4% of RIS). Meta-regression showed that, compared with midazolam, melatonin dose was significantly correlated with the effect (P = 0.024). The risk ratios (95% CI) of low and high-dose melatonin were 1.02 (0.39 to 2.65) and 0.22 (0.08 to 0.58), respectively. There was no effect of melatonin compared with dexmedetomidine (risk ratio 1.0, 95% CI 0.15 to 6.55). TSA-adjusted 95% CI could not be calculated (0.9% of RIS). CONCLUSION: Compared with placebo, melatonin premedication may be effective in preventing emergence agitation in children (GRADE: low). This TSA suggests that further studies are required to confirm the results. Compared with midazolam, high-dose melatonin might have a significant effect in preventing emergence agitation (GRADE: very low). The study protocol was registered in the UMIN Clinical Trials Registry (registration number: UMIN000011841).