Dataset Information

Efficacy of premedication with intravenous midazolam on preoperative anxiety and mask compliance in pediatric patients: a randomized controlled trial.

ABSTRACT:

Background

To alleviate anxiety before surgery is a significant concern for the pediatric anesthesiologist. Midazolam has been generally used as a premedication, and compelling data regarding effective dose to mitigate anxiety is lacking. The current trial addressed the comparable efficacy of intravenous midazolam with different doses regarding the anxiety state, ease of child-parental separation, and mask compliance as premedication in pediatric patients undergoing tonsillectomy.

Methods

Three hundred and twelve children aged 2-8 years were randomly assigned, 104 per group, to receive intravenous 0.03 mg/kg midazolam (group A), 0.05 mg/kg midazolam (group B), or saline control (group C), 40 minutes before surgery. We assessed the anxiety state every 10 min after premedication with modified Yale preoperative anxiety scale (mYPAS), evaluated the emotional state during separation with parental separation anxiety scale (PSAS), and compared their compliance to mask oxygen supply with mask acceptance score (MAS).

Results

Children premedicated with 0.05 mg/kg midazolam achieved a sedated state more rapidly than those who received 0.03 mg/kg midazolam (5.9±2.3 vs. 7.0±3.9, P=0.02). The proportion of satisfactory parental separation and compliance to mask ventilation was not different between midazolam groups, which was superior to saline control. The children receiving 0.05 mg/kg midazolam stayed longer in postoperative care unit than those receiving 0.03 mg/kg midazolam and saline. The incidence of postoperative adverse events was rare and comparable among groups.

Conclusions

Intravenous administration of a single dose of midazolam 0.05 and 0.03 mg/kg produces similar effects on sedation status, parental separation, and mask induction acceptance, except for rapid-onset and long sedation duration in pediatric patients premedicated with 0.05 mg/kg midazolam.

Trial registration

ClinicalTrials.gov NCT04266340.

SUBMITTER: Qiao H

PROVIDER: S-EPMC9732608 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Efficacy of premedication with intravenous midazolam on preoperative anxiety and mask compliance in pediatric patients: a randomized controlled trial.

Qiao Hui H Chen Jing J Lv Peipei P Ye Zhou Z Lu Yu Y Li Wenxian W Jia Jie J

Translational pediatrics 20221101 11

<h4>Background</h4>To alleviate anxiety before surgery is a significant concern for the pediatric anesthesiologist. Midazolam has been generally used as a premedication, and compelling data regarding effective dose to mitigate anxiety is lacking. The current trial addressed the comparable efficacy of intravenous midazolam with different doses regarding the anxiety state, ease of child-parental separation, and mask compliance as premedication in pediatric patients undergoing tonsillectomy.<h4>Met ...[more]

PMID: 36506775

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Project description:BackgroundPatients undergoing surgery and general anesthesia often experience anxiety, fear and stress, with negative bodily responses. These may be managed by the pre-procedural application of anxiolytic, analgesic, and anesthetic drugs that have, however, potential risks or side effects. Music therapy (MT) can be used as a complementary no-drug intervention alongside standard surgical care before, during and after medical procedures. The aim of this study was to evaluate the effects of preoperative MT intervention compared to premedication with midazolam on levels of anxiety, sedation and stress during general anesthesia for elective stomatology surgery.MethodsA two-arm randomized and controlled single-center, parallel-group, pre-post event study was conducted. In total, 70 patients affected by stage I or II (both clinically and instrumentally N0) micro-invasive oral cancer and undergoing elective surgery under general anesthesia were assigned to the control group (CG) or to the music therapy group (MTG). MTG patients received preoperative music therapy intervention (MT) from a certified music therapist before surgery, while the CG patients did not receive MT but instead received premedication with intravenous midazolam, 0.02 mg/kg. Anesthesia was the same in both groups. The systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were recorded at the entrance to the operating room, just before the induction of anesthesia and every 5 min until the end of surgery. An anxiety visual analogues scale (A-VAS) was used to evaluate the level of anxiety. The bispectral index (BIS) monitor was used to measure the depth of sedation just before and 10 min after both music intervention and midazolam administration. Stress response was assessed 5 min before and 20 min after surgery via the control of plasma prolactin (PRL), growth hormone (GH), and cortisol levels. The patient global impression of satisfaction (PGIS) was tested 1 h after surgery. Participants in the MTG were asked to answer 3 questions concerning their experience with MT.ResultsNo statistical differences among the PRL, GH and cortisol levels between the two groups were registered before and after the treatment, as well as for PAS, PAD and HR. Significant differences in the A-VAS scores between the MTG and CG (p < 0.01) was observed. Compared to the CG, MTG patients had a statistically significantly lower BIS score (p = 0.02) before induction. A PGIS score of 86.7% revealed that patients in the MTG were very satisfied, versus 80% in the CG (p < 0.05).ConclusionPreoperative music therapy could be an alternative to intravenous midazolam when aiming to promote a preoperative and post-operative state of anxiolysis and sedation in stomatology surgery, even if no differences were found in terms of the surgery-related stress response according to physiological and hormonal determinations.

Project description:BackgroundIntranasal midazolam and ketamine have been widely used as sedative premedication in children. It is difficult to determine which one yields better sedative effects for clinical practice. We conducted the present meta-analysis by summarizing the evidences to evaluate the efficacy and safety of intranasal midazolam versus intranasal ketamine as sedative premedication in pediatric patients.MethodsWe searched PubMed, Embase, and Cochrane Library from inception to April 2022. All randomized controlled trials (RCTs) used intranasal midazolam and ketamine as sedatives in children were enrolled. The risk of bias in RCTs was assessed by Cochrane risk of bias tool. Condition of parental separation, anesthesia induction or facemask acceptance, sedation level, different hemodynamic parameters and adverse events were considered as the outcomes in our study.ResultsA total of 16 studies with 1066 patients were enrolled. Compared with midazolam, administration of intranasal ketamine might be associated with severer changes in hemodynamics parameters including mean blood pressure (SMD = -0.53, with 95% CI [-0.93, -0.13]) and heart rate (HR) (SMD = -1.39, with 95% CI [-2.84, 0.06]). Meanwhile, administration of intranasal midazolam was associated with more satisfactory sedation level (61.76% vs 40.74%, RR = 1.53, with 95%CI [1.28, 1.83]), more rapid onset of sedation (SMD = -0.59, with 95%CI [-0.90, -0.28]) and more rapid recovery (SMD = -1.06, with 95%CI [-1.83, -0.28]). Current evidences also indicated that the differences of various adverse effects between two groups were not significant.ConclusionsGiven that administration of midazolam via intranasal route provides more satisfactory sedative level with less fluctuation of hemodynamics parameters and more rapid onset and recovery, it might be considered as the preferred sedative premedication for pediatric patients compared to ketamine. However, the widespread evidences with low or moderate quality indicated that superiority of intranasal midazolam in pediatric sedation needs to be confirmed by more studies with high quality and large sample size in future.Trial registrationThe protocol of present study was registered with PROSPERO (CRD42022321348).

Project description:PurposeMask ventilation is the most widely used method to provide ventilation during anesthesia induction. Appropriate head and neck positions, exaggerated jaw lifts, two-hand and two-person ventilation, and the use of oral or nasal airways can facilitate mask ventilation. Neuromuscular blockers and premedication drugs such as midazolam and dexmedetomidine have also been proposed to facilitate mask ventilation. The hypothesis of this study was that midazolam premedication would facilitate mask ventilation in children.MethodsChildren aged 2-10 years were randomized into two groups. The midazolam group (Group M) received an intravenous dose of midazolam premedication (0.1 mg/kg, maximum dose 3 mg), and the control group received an intravenous dose of saline of the same volume (Group C). The primary outcome of the study was to examine the effect of midazolam premedication on mask ventilation in children, using the Han mask grading scale.ResultsThe data of 120 children were analyzed (n = 60 in Group M, n = 60 in Group C). According to the Han mask grading scale, the scores of the patients in the midazolam group were significantly lower than those of the control group. The distribution of Han scores was significantly different between the groups (p < 0.001). In the midazolam group, 93.3% of the children had a Han score of 1 and 6.7% had 2, and in the control group, 60% had a score of 1, and 40% had 2. In the subgroup analysis of overweight children, a Han score of 1 was determined in 91.7% of the midazolam group and 61.1% of the control group (p = 0.03).ConclusionIn conclusion, the results of this clinical research demonstrated that midazolam premedication improves mask ventilation in children during general anesthesia induction. The findings also showed that the effect of midazolam in facilitating mask ventilation was similar in overweight children.Clinical trial registrationThe study was registered in clinicaltrials.gov (trial ID: NCT05368441 on 10/05/2022).

Project description:BackgroundPerioperative anxiety is common in pediatric patients undergoing surgery.AimsThe aim of this study was to determine whether an infusion of dexmedetomidine prior to hernia repair in children provides better postoperative anxiety outcomes that a preoperative infusion of midazolam.MethodsNinety 6-11-year-old children, who were scheduled to undergo elective hernia repair, were enrolled for this double-blind, randomized controlled trial. Group D (n = 45) received an intravenous infusion of dexmedetomidine (0.5 μg/kg) and Group M (n = 45) received an intravenous infusion of midazolam (0.08 mg/kg) in 20 mL of normal saline for 10 minutes before the induction of anesthesia. Pre- and postoperative scores on the modified Yale Preoperative Anxiety Scale were the main outcomes. Secondary outcomes included systolic blood pressure, diastolic blood pressure, heart rate, and postoperative pain measured on a visual analogue scale and patient satisfaction using a numerical rating scale.ResultsPostoperative anxiety in Group D was significantly lower than preoperative anxiety (2 hours postoperatively mean difference [95% CI]: 2.83 [0.87-4.79], P = 0.036, 4 hours postoperatively mean difference [95% CI]: 3.29 [1.39-5.20], P = 0.005). Preoperative and postoperative anxiety in Group M was similar. Anxiety scores in Group D were also significantly lower than anxiety in Group M 2 hours (mean difference [95% CI]: 1.89 [0.52-3.26], P = 0.01) and 4 hours (mean difference [95% CI]: 3.32 [1.98-4.66], P < 0.001) postoperatively. Systolic blood pressure, diastolic blood pressure and heart rate were lower in Group D than in Group M after administration of sedative drugs until children left PACU (SBP mean difference [95% CI]: 13.87 [10.30-17.43], P < 0.001, DBP mean difference [95% CI]: 5.96[3.80-8.11], P < 0.001, HR mean difference [95% CI]: 10.36 [7.58-13.13], P < 0.001). Pain was also significantly lower in Group D than in Group M at 2 hours (median difference [95% CI]: 1 [0.26-1.34], P = 0.004), 4 hours (median difference [95% CI]: 1 [0.31-1.02], P = 0.003), and 1 day (median difference [95% CI]: 0 [0.22-0.76], P = 0.003) postoperatively. Patient satisfaction scores were significantly higher in Group D than in Group M 1 day (median difference [95% CI]: 0 [-0.83 to -0.24], P = 0.006) and somewhat higher 1 week (median difference [95% CI]: 0 [-0.67 to -0.04], P = 0.06) postoperatively.ConclusionCompared with midazolam, a single preoperative intravenous dose of dexmedetomidine appears to provide better postoperative anxiolytic effects for children undergoing same-day surgery.

Project description:BACKGROUND:Midazolam premedication is widely used before general anesthesia, but lacks clinical evidence of effectiveness. The present study aimed to evaluate the effectiveness of midazolam premedication following 4 aspects: anxiety reduction, sedation, hemodynamic stabilization, and analgesia. METHODS:In a randomized, single-blind, prospective study, a total of 128 women were allocated to the midazolam premedication group (Group P, n?=?64) or the control group (Group N, n?=?64). The patients were asked to complete the Beck anxiety inventory (BAI) 2 times: on the day before surgery (BS) and 30?minutes after midazolam premedication (T0). Depth of anesthesia using state entropy (SE), conventional hemodynamic data using heart rate (HR) and mean blood pressure (MBP), and analgesic profiles using surgical pleth index (SPI) were acquired at the following 4 points: T1-pre-induction, T2-prior to intubation, T3-intubation, and T4-20?minutes after intubation. RESULTS:No change in BAI score was observed between BS and T0 in both groups P and N (median and interquartile range [IQR], Group P: BS-4.5 [2.0-7.0], T0-4.0 [1.0-9.0], P?=?.603; Group N: BS-4.0 [1.0-8.5], T0-3.5 [1.0-6.0], P?=?.066). Midazolam premedication reduced SE at T2-4 (mean difference with 95% confidence interval [95% CI], T2-7.1 [1.6-12.6], P?=?.012; T3-10.4 [6.5-14.4], P?<?.001; T4-9.2 [5.0-13.4], P?<?.001). Midazolam premedication also reduced HR (mean differences [95% CI], T1-7.3 [2.5-12.1], P?=?.003; T3-6.6 [1.1-12.2], P?=?.020) and MBP at T1 and T3 (mean differences [95% CI], T1-7.3 [2.5-12.1], P?=?.003; T3-8.6 [1.3-15.9], P?=?.021), and lowered SPI at T1-3 (mean differences [95% CI]: T1-12.7 [6.1-19.4], P?<?.001; T2-6.0 [0.5-11.5], P?=?.033; T3-7.9 [1.7-14.1], P?=?.012). CONCLUSION:Midazolam premedication did not reduce the level of anxiety. However, midazolam premedication reduced the entropy values, stabilized hemodynamics, and provided analgesia during the induction of anesthesia. The purpose of midazolam premedication needs to be reconsidered.

Project description:BackgroundPediatric patients undergoing surgery frequently experience significant anxiety, which can result in adverse effects such as prolonged sedation and behavioral changes associated with pharmacological interventions such as oral midazolam. Video games offer a nonpharmacological distraction method that shows promise in alleviating procedural anxiety without significant adverse effects. However, the effectiveness of video games compared to midazolam in managing perioperative anxiety remains uncertain.ObjectiveThis study aimed to evaluate the effectiveness of video game interventions in reducing perioperative anxiety in pediatric patients undergoing general anesthesia.MethodsWe conducted a comprehensive search across PubMed, Embase, Web of Science, and the Cochrane Library, supplemented by reference screening. Primary outcomes included anxiety levels assessed during parent separation and mask induction procedures, while secondary outcomes encompassed emergence delirium, postoperative behavior, and length of stay in the postanesthesia care unit (PACU). The risk of bias was assessed using the Risk of Bias 2 scale. Data were synthesized descriptively and through meta-analysis, with the certainty of the evidence evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria.ResultsSix randomized controlled trials involving 612 participants were included in the analysis. Children who participated in video game interventions reported significantly lower anxiety levels during parent separation (standardized mean difference, SMD -0.31, 95% CI -0.50 to -0.12; P=.001), with high certainty, and during mask induction (SMD -0.29, 95% CI -0.52 to -0.05; P=.02), with moderate certainty, compared to those receiving oral midazolam. Additionally, significant differences in postoperative behavior changes in children were observed compared to oral midazolam (SMD -0.35, 95% CI -0.62 to -0.09; P=.008). Children in the video game intervention groups also had a shorter length of stay in the PACU (mean difference, MD -19.43 min, 95% CI -31.71 to -7.16; P=.002). However, no significant differences were found in emergence delirium (MD -2.01, 95% CI -4.62 to 0.59; P=.13).ConclusionsVideo game interventions were more effective than midazolam in reducing perioperative anxiety among pediatric patients, improving postoperative behavior, and shortening the length of stay in the PACU. However, video games alone did not outperform midazolam in managing emergence delirium. Further high-quality research is needed for more conclusive results.

Dataset Information

Efficacy of premedication with intravenous midazolam on preoperative anxiety and mask compliance in pediatric patients: a randomized controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Efficacy of premedication with intravenous midazolam on preoperative anxiety and mask compliance in pediatric patients: a randomized controlled trial.

Similar Datasets

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