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Background Studies conducted in adults undergoing surgery reported a beneficial effect of oral melatonin administered before surgery. There is a paucity of such data in children undergoing anesthesia and surgery. Methods Children undergoing surgery were randomly assigned to receive preoperatively oral midazolam 0.5 mg/kg or oral melatonin 0.05 mg/kg, 0.2 mg/kg, or 0.4 mg/kg. The primary outcome of the study was preoperative anxiety (Yale Preoperative Anxiety Scale). The secondary outcomes were the children's compliance with induction (Induction Compliance Checklist), emergence behavior (Keegan scale), and parental anxiety (State-Trait Anxiety Inventory). Results Repeated measures ANOVA showed that children who received melatonin at any of the three doses were more anxious compared with children who received midazolam (P < 0.001). Parental anxiety did not differ on the basis of the experimental condition (P = ns). The melatonin groups showed a dose-response effect on emergence behavior. Children who received melatonin developed less emergence delirium compared with those who received midazolam (P < 0.05), and the effect was dose related; the incidence after 0.05 mg/kg melatonin was 25.0%, incidence after 0.2 mg/kg melatonin was 8.3%, and incidence after 0.4 mg/kg melatonin was 5.4%. Conclusions Midazolam is more effective than melatonin in reducing children's anxiety at induction of anesthesia. Melatonin showed a direct dose-dependent effect on emergence delirium.

Background Children and parents experience significant anxiety and distress during the preoperative period. Currently available interventions are having limited efficacy. Based on an integration of the literature in both the anesthesia and psychological milieus, the authors developed a behaviorally oriented perioperative preparation program for children undergoing surgery that targets the family as a whole. Methods Children and their parents (n = 408) were randomly assigned to one of four groups: (1) control: received standard of care; (2) parental presence: received standard parental presence during induction of anesthesia; (3) ADVANCE: received family-centered behavioral preparation; and (4) oral midazolam. The authors assessed the effect of group assignment on preoperative anxiety levels and postoperative outcomes such as analgesic consumption and emergence delirium. Results Parents and children in the ADVANCE group exhibited significantly lower anxiety in the holding area as compared with all three other groups (34.4+/-16 vs. 39.7+/-15; P=0.007) and were less anxious during induction of anesthesia as compared with the control and parental presence groups (44.9+/-22 vs. 51.6+/-25 and 53.6+/-25, respectively; P=0.006). Anxiety and compliance during induction of anesthesia was similar for children in both the ADVANCE and midazolam groups (44.9+/-22 vs. 42.9+/-24; P=0.904). Children in the ADVANCE group exhibited a lower incidence of emergence delirium after surgery (P=0.038), required significantly less analgesia in the recovery room (P=0.016), and were discharged from the recovery room earlier (P=0.04) as compared with children in the three other groups. Conclusion The family-centered preoperative ADVANCE preparation program is effective in the reduction of preoperative anxiety and improvement in postoperative outcomes.

Background The authors suggest that research in the area of parental presence during induction of anesthesia should shift to emphasize what parents actually do during induction, rather than focusing simply on their presence. As a first step, the authors aimed to develop a behavioral coding system that would measure child and adult interactions in the perioperative environment. Methods The authors enrolled 45 parents and children (aged 2-12 yr) undergoing elective surgery and general anesthesia. A multidisciplinary team examined videotapes and transcriptions of interactions between children, parents, and medical personnel in the holding room and operating room. The team used an existing scale, the Child-Adult Medical Procedure Interaction Scale, as the prototype for the development of a new perioperative behavioral coding system. The research team conducted extensive revisions to the original scale and added multiple codes to the original scale, including nonverbal codes. Interrater reliability was assessed using weighted kappa statistics. Construct validity was also examined. Results The final Perioperative Child-Adult Medical Procedure Interaction Scale contains 40 codes in four domains. Analyses showed excellent reliability overall for verbal and nonverbal codes. Kappa values averaged 0.87 for verbal codes characterizing adult vocalizations, 0.92 for verbal codes characterizing child vocalizations, and 0.88 for nonverbal codes. Construct validity was demonstrated by finding the hypothesized associations between certain scale codes and children's anxiety (P = 0.0001). Conclusion Showing excellent reliability, the Perioperative Child-Adult Medical Procedure Interaction Scale is an appropriate tool for assessing child-adult behavioral interaction during the perioperative period. When sequential analyses are conducted and target behaviors are identified, empirically based parent preparation programs can be developed.

Background The authors conducted a double-blind, randomized, controlled trial to determine whether the use of sevoflurane in children undergoing anesthesia and surgery results in a higher incidence of postoperative maladaptive behavioral changes as compared with halothane. Methods Children and their parents (n = 102) were randomly assigned to either a halothane group (n = 50) or a sevoflurane group (n = 52). The intraoperative anesthetic protocol was strictly controlled, and the postoperative analgesic consumption and pain levels were recorded. The effect of the group assignment on emergence status and maladaptive postoperative behavioral changes was assessed both by validated psychological measures and physiologic instruments (actigraphy) on postoperative days 1-7. Anxiety of the parent and child was also assessed, as was the child's postoperative recovery (Recovery Inventory). Results There were no group differences in preoperative state anxiety, postoperative analgesic requirements, postoperative pain, or the incidence of emergence delirium (P = not significant). Two-way repeated-measures analysis of variance showed no group differences in the incidence of postoperative maladaptive behaviors (F4,72 = 0.60, P = 0.701) or actigraphic variables such as percent sleep, number of night awakenings, and night awakenings that lasted for more than 5 min (P = not significant). Conclusion The authors found no increased incidence of emergence delirium, maladaptive postoperative behavior changes, or sleep disturbances in children undergoing anesthesia with sevoflurane as compared with halothane.

Background The authors conducted a randomized controlled trial to determine whether parental presence during induction of anesthesia (PPIA) is associated with parental physiologic and behavioral manifestations of stress. Methods Children and their parents (N = 80) were randomly assigned to one of three groups: (1) PPIA; (2) PPIA plus 0.5 mg/kg oral midazolam; and (3) control (no PPIA or midazolam). The effect of the group assignment on parental heart rate (HR), parental blood pressure, and parental skin conductance level (SCL) were assessed. Both parental HR and parental SCL were monitored continually. Anxiety of the parent and child was also assessed. Results Parental HR increased from baseline until the induction of anesthesia (P = 0.001). A group-by-time effect ( P= 0.005) was also found. That is, throughout the induction period there were several time points at which parents in the two PPIA groups had a significantly higher HR than did parents in the control group (P < 0.05). Similarly, SCL was found to increase in all parents from baseline until induction of anesthesia (P = 0.001). Significant group differences in SCL changes over time were found as well (P = 0.009). State anxiety and blood pressure following induction of anesthesia did not differ significantly between groups ( P= nonsignificant). Examination of parental Holter data revealed no rhythm abnormalities and no electrocardiogram changes indicating ischemia. Conclusions The authors found that PPIA is associated with increased parental HR and SCL. However, no increased incidence of electrocardiogram abnormalities were found in parents present during induction of anesthesia.

Background The minimum time interval between administration of oral midazolam and separation of children from their parents that ensures good anterograde amnesia has not been previously determined. This is of particular importance in a busy operating room setting where schedule delays secondary to midazolam administration may not be tolerated. Methods Children (n = 113) undergoing general anesthesia and surgery completed preoperative baseline memory testing using a validated series of picture cards and were randomly assigned to one of three midazolam groups or a control group. Exactly, 5, 10, or 20 min after receiving oral midazolam (0.5 mg/kg) or 15 min after receiving placebo, children were administered a second memory test that used pictures. Anxiety of children was assessed during induction of anesthesia with use of a validated anxiety measurement tool. Postoperatively, recall and recognition for picture cards seen during baseline testing and postintervention testing were assessed. Results Postoperatively, recall and recognition of pictures presented to patients after drug administration (anterograde amnesia) showed significant group differences (P = 0.0001), with recall impaired in the 10- (P = 0.004) and 20-min groups (P = 0.0001). Similarly, recognition memory was impaired in the 5- (P = 0.0008), 10- (P = 0.0001) and 20-min (P = 0.0001) groups. Significant anxiolytic effects of midazolam were observed as early as 15 +/- 4 min after midazolam administration (P = 0.02). Conclusions Midazolam administered orally produces significant anterograde amnesia when given as early as 10 min before a surgical procedure.

Background Although some anesthesiologists use oral sedatives or parental presence during induction of anesthesia (PPIA) to treat preoperative anxiety in children, others may use these interventions simultaneously (e.g., sedatives and PPIA). The purpose of this investigation was to determine whether this approach has advantages over treating children with sedatives alone. Methods The child's and the parental anxiety throughout the perioperative period was the primary endpoint of the study. Parental satisfaction was the secondary endpoint. Subjects (n = 103) were assigned randomly to one of two groups: a sedative group (0.5 mg/kg oral midazolam) or a sedative and PPIA group. Using standardized measures of anxiety and satisfaction, the effects of the interventions on the children and parents were assessed. Statistical analysis (varimax rotation) of the satisfaction questionnaire items resulted in two factors that described satisfaction of the separation process and satisfaction of the overall care provided. Results Anxiety in the holding area, at entrance to the operating room, and at introduction of the anesthesia mask did not differ significantly between the two groups (F[2,192] = 1.26, P = 0.28). Parental anxiety after separation, however, was significantly lower in the sedative and PPIA group (F[2,93] = 4.46, P = 0.037). Parental satisfaction with the overall care provided (-0.28 +/- 1.2 vs. 0.43 +/- 0.26, P = 0.046) and with the separation process (-0.30 +/- 1.2 vs. 0.47 +/- 0.20, P = 0.03) was significantly higher among the sedative and PPIA group compared with the sedative group. Conclusions PPIA in addition to 0.5 mg/kg oral midazolam has no additive effects in terms of reducing a child's anxiety. Parents who accompanied their children to the operating room, however, were less anxious and more satisfied.

Background Both midazolam and parental presence during induction of anesthesia are routinely used to treat preoperative anxiety in children. The purpose of this investigation was to determine which of these two interventions is more effective. Methods Anxiety of the child during the perioperative period was the primary end point. Secondary end points included anxiety of the parent and compliance of the child during induction. Children (n = 88) were randomly assigned to one of three groups: (1) 0.5 mg/kg oral midazolam; (2) parental presence during induction of anesthesia; or (3) control (no parental presence or premedication). Using multiple behavioral measures of anxiety, the effect of the intervention on the children and their parents was assessed. Results Observed anxiety in the holding area (T1), entrance to the operating room (T2), and introduction of the anesthesia mask (T3) differed significantly among the three groups (P = 0.032). Post hoc analysis indicated that children in the midazolam group exhibited significantly less anxiety compared with the children in the parental-presence group or control group (P = 0.0171). Similarly, parental anxiety scores after separation were significantly less in the midazolam group compared with the parental-presence or control groups (P = 0.048). The percentage of inductions in which compliance of the child was poor was significantly greater in the control group compared with the parental-presence and midazolam groups (25% vs. 17% vs. 0%, P = 0.013). Conclusions Under the conditions of this study, oral midazolam is more effective than either parental presence or no intervention for managing a child's and parent's anxiety during the preoperative period.

Background Cocaine use in the United States is prevalent among pregnant women from inner city neighborhoods. To determine the anesthetic implications of cocaine use in parturients undergoing cesarean section delivery, the authors conducted a cohort study. Methods One thousand nine hundred seven women presenting for prenatal care were interviewed regarding substance abuse. Urine was analyzed for benzoylecgonine, tetrahydracannabinol, benzodiazepines, and opioids. Next all parturients who underwent cesarean section delivery were identified and their records reviewed for anesthetic and obstetric outcomes. Results Among the 51 women who were classified as cocaine abusers, the most frequent reasons for cesarean section were fetal distress (48%) and abruptio placenta (21%). In a multivariate model, cocaine abuse before delivery was shown to be an independent predictor of preoperative diastolic hypertension (F = 10.6, P = 0.01). Similarly, univariate analysis showed that immediately after intubation, diastolic blood pressure was significantly higher among parturients who used cocaine (99 +/- 13 mmHg v. 87 +/- 18 mmHg; P = 0.02). In contrast, epidural anesthesia was associated with hypotension significantly more often among cocaine-abusing parturients (44% vs. 10%; P = 0.04). A higher rate of perioperative wheezing was reported among patients who abused cocaine (16% vs. 6%; relative risk = 2.7); this finding, however, did not persist in multivariate analysis. Operative blood loss was similar in all groups (P = NS), and no ventricular dysrhythmias or cerebrovascular or coronary ischemic episodes were reported in any of the parturients. Conclusions Although cocaine-abusing parturients are at higher risk for interim peripartum events such as hypertension, hypotension, and wheezing episodes, there is no significant increase in rates of maternal morbidity or death.

Background To determine whether parental presence during induction of anesthesia is an effective preoperative behavioral intervention, a randomized controlled trial with children undergoing outpatient surgery was conducted. Methods Eighty-four children were randomly assigned to a parent-present or parent-absent group. Using multiple behavioral and physiologic measures of anxiety, the effect of the intervention on the children and their parents was assessed. Predictors for the response to the intervention were examined using multivariate linear regression analysis. Results When the intervention group (parent-present) was compared to the control group (parent-absent), overall there were no significant differences in any of the behavioral or physiologic measures of anxiety tested during induction of anesthesia. Using the child's serum cortisol concentration as the outcome, parental presence, the child's age and baseline temperament, and trait anxiety of the parent, were identified as predictors of the child's anxiety during induction. Analysis of variance demonstrated that three groups showed diminished cortisol concentrations with parental presence: children older than 4 yr (P = 0.001), children whose parent had a low trait anxiety (P = 0.02), and children who had a low baseline level of activity as assessed by temperament (P = 0.05). Conclusions Children who were older than 4 yr or those with a parent with a low trait anxiety or who had a low baseline level of activity/temperament benefited from parental presence during induction.

Background: Multiple studies document the beneficial effect of midazolam on preoperative anxiety in children. Many clinicians report, however, that some children may in fact not benefit from the administration of this drug. Methods: After screening for relevant exclusion criteria, children undergoing surgery were enrolled in the study (n 262) and received 0.5 mg/kg oral midazolam at 20‐40 min before induction of anesthesia. Personality instruments were administered to all children, and anxiety levels were evaluated before and after administration of midazolam as well as during induction of anesthesia. Blood was drawn during the induction process and later analyzed for midazolam levels. A priori definitions of responders and nonresponders to midazolam were established using a multidisciplinary task force, videotapes of induction, and a validated and reliable anxiety scale, the modified Yale Preoperative Anxiety Scale. Results: While 57% of all children scored at the minimum of the modified Yale Preoperative anxiety scale, 14.1% of children fell in the a priori defined group of midazolam nonresponders. Midazolam blood levels (94 41 vs. 109 40 ng/ml) and timing between administration of midazolam and induction (28 9 vs. 29 8 min) did not differ between midazolam responders and nonresponders. In contrast, midazolam nonresponders were younger (4.2 2.3 vs. 5.9 2.0 yr), more anxious preoperatively (49.7 22.9 vs. 38.3 19.1), and higher in emotionality (13.6 3.6 vs. 11.3 3.8) as compared with responders (P < 0.05). Conclusions: Although midazolam is an effective anxiolytic for most children, 14.1% of children still exhibit extreme distress. This subgroup is younger, more emotional, and more anxious at baseline. Future studies are needed to determine the best strategy to treat these children. ALTHOUGH the exact prevalence of preoperative anxiety in children is difficult to estimate because of measurement difficulties and developmental variation, up to 50% of children undergoing surgery are reported to exhibit significant manifestations of anxiety in the preoperative period. 1 Both psychological and pharmacologic interventions are available to treat preoperative anxiety in children. Among the preoperative pharmacologic interventions, midazolam is the most commonly used drug in the United States. 2,3 Indeed, a recent largescale national survey study indicated that when a preoperative sedative is given to children, midazolam is the choice in more than 90% of cases and that midazolam is mostly administered before surgery orally at a dose of 0.5 mg/kg. 3 Although midazolam has been reported to pro

The authors suggest that research in the area of parental presence during induction of anesthesia should shift to emphasize what parents actually do during induction, rather than focusing simply on their presence. As a first step, the authors aimed to develop a behavioral coding system that would measure child and adult interactions in the perioperative environment.The authors enrolled 45 parents and children (aged 2-12 yr) undergoing elective surgery and general anesthesia. A multidisciplinary team examined videotapes and transcriptions of interactions between children, parents, and medical personnel in the holding room and operating room. The team used an existing scale, the Child-Adult Medical Procedure Interaction Scale, as the prototype for the development of a new perioperative behavioral coding system. The research team conducted extensive revisions to the original scale and added multiple codes to the original scale, including nonverbal codes. Interrater reliability was assessed using weighted kappa statistics. Construct validity was also examined.The final Perioperative Child-Adult Medical Procedure Interaction Scale contains 40 codes in four domains. Analyses showed excellent reliability overall for verbal and nonverbal codes. Kappa values averaged 0.87 for verbal codes characterizing adult vocalizations, 0.92 for verbal codes characterizing child vocalizations, and 0.88 for nonverbal codes. Construct validity was demonstrated by finding the hypothesized associations between certain scale codes and children's anxiety (P = 0.0001).Showing excellent reliability, the Perioperative Child-Adult Medical Procedure Interaction Scale is an appropriate tool for assessing child-adult behavioral interaction during the perioperative period. When sequential analyses are conducted and target behaviors are identified, empirically based parent preparation programs can be developed.

Background The authors developed a measure to determine whether maternal motivation to be present during induction (Motivation for Parental Presence during Induction of Anesthesia [MPPIA]) is related to children's anxiety during the induction process. Methods Mothers and children (aged 2-12 yr) undergoing outpatient, elective surgery and general anesthesia were enrolled in this study (n = 289 dyads). Items to assess motivation for parental presence during induction were selected by experts in anesthesiology, psychology, and child development; mothers completed the resulting 14-item measure as well as assessments of anxiety and coping style. Children's anxiety and compliance was assessed during induction of anesthesia. Factor analysis was performed, and maternal motivation was then examined against children's anxiety during induction of anesthesia. Results Factor analysis resulted in four scales with a total variance of 72.3%: MPPIA-Desire, MPPIA-Hesitancy, MPPIA-Anxiety, and MPPIA-Preparation. Analysis supported the reliability (0.89-0.94) and validity of the MPPIA. The authors found that mothers with high MPPIA-Desire and low MPPIA-Hesitancy had children with significantly higher anxiety (P < 0.0001) during induction of anesthesia, as compared with mothers with low MPPIA-Desire and MPPIA-Hesitancy. The authors also found that highly motivated mothers reported significantly higher levels of anxiety (P = 0.007). Conclusion Clinicians should be aware that many mothers who have a high desire to be present in the operating room are very anxious and that their children are likely to exhibit high anxiety levels during induction of anesthesia.

The authors conducted a double-blind, randomized, controlled trial to determine whether the use of sevoflurane in children undergoing anesthesia and surgery results in a higher incidence of postoperative maladaptive behavioral changes as compared with halothane.Children and their parents (n = 102) were randomly assigned to either a halothane group (n = 50) or a sevoflurane group (n = 52). The intraoperative anesthetic protocol was strictly controlled, and the postoperative analgesic consumption and pain levels were recorded. The effect of the group assignment on emergence status and maladaptive postoperative behavioral changes was assessed both by validated psychological measures and physiologic instruments (actigraphy) on postoperative days 1-7. Anxiety of the parent and child was also assessed, as was the child's postoperative recovery (Recovery Inventory).There were no group differences in preoperative state anxiety, postoperative analgesic requirements, postoperative pain, or the incidence of emergence delirium (P = not significant). Two-way repeated-measures analysis of variance showed no group differences in the incidence of postoperative maladaptive behaviors (F4,72 = 0.60, P = 0.701) or actigraphic variables such as percent sleep, number of night awakenings, and night awakenings that lasted for more than 5 min (P = not significant).The authors found no increased incidence of emergence delirium, maladaptive postoperative behavior changes, or sleep disturbances in children undergoing anesthesia with sevoflurane as compared with halothane.

The authors conducted a randomized controlled trial to determine whether parental presence during induction of anesthesia (PPIA) is associated with parental physiologic and behavioral manifestations of stress.Children and their parents (N = 80) were randomly assigned to one of three groups: (1) PPIA; (2) PPIA plus 0.5 mg/kg oral midazolam; and (3) control (no PPIA or midazolam). The effect of the group assignment on parental heart rate (HR), parental blood pressure, and parental skin conductance level (SCL) were assessed. Both parental HR and parental SCL were monitored continually. Anxiety of the parent and child was also assessed.Parental HR increased from baseline until the induction of anesthesia (P = 0.001). A group-by-time effect ( P= 0.005) was also found. That is, throughout the induction period there were several time points at which parents in the two PPIA groups had a significantly higher HR than did parents in the control group (P0.05). Similarly, SCL was found to increase in all parents from baseline until induction of anesthesia (P = 0.001). Significant group differences in SCL changes over time were found as well (P = 0.009). State anxiety and blood pressure following induction of anesthesia did not differ significantly between groups ( P= nonsignificant). Examination of parental Holter data revealed no rhythm abnormalities and no electrocardiogram changes indicating ischemia.The authors found that PPIA is associated with increased parental HR and SCL. However, no increased incidence of electrocardiogram abnormalities were found in parents present during induction of anesthesia.

Background A significant number of children undergoing anesthesia and surgery exhibit new-onset sleep-related problems postoperatively. The aim of this longitudinal cohort study was to expand previous research in this area by using a new objective technology. Methods This study compared children undergoing general anesthesia and outpatient surgery (n = 92) to a community-based control group of children (n = 77). Data regarding coping, temperament, anxiety, surgical procedures, and postoperative pain were collected. Subjects underwent actigraphy sleep monitoring for at least 3 nights before surgery and 5 postoperative days (POD). Sleep assessment was performed with actigraphy sleep monitoring and the Post Hospitalization Behavioral Questionnaire (PHBQ). Results Forty-three children (47%) in the surgery group experienced postoperative sleeping disturbances as determined by either the actigraphy or the PHBQ. Only 13 children (14.4%), however, experienced a decrease of at least 1 SD in percentage sleep as assessed by actigraphy. Postoperative pain scores on POD 1 and POD 2 were significantly higher among children who exhibited sleep problems as diagnosed by actigraphy (F = 4.283; P= 0.047). Also, children who exhibited actigraph-based sleep problems scored lower sociability-temperament (14.1 +/- 4.3 vs. 17.5 +/- 3.4; P= 0.04) scores compared with the community group and had a higher rate of change in their perioperative anxiety levels (group x time interaction, F = 5.1; P= 0.03). Conclusion A significant number of children undergoing outpatient surgery experience postoperative sleep-related problems. The clinical significance of this finding, however, is unclear.