Intramuscular midazolam premedication in small children

Midazolam 0.2 mg/kg was compared as an intramuscular premedication in small children with papaveretum and hyoscine 0.4 and 0.008 mg/kg. Midazolam produced satisfactory sedation and anxiolysis and in the early postoperative period patients were significantly more awake (p less than 0.05).     

Oral midazolam premedication and postoperative behaviour in children

We examined the effect of oral midazolam premedication on postoperative behaviour. Seventy children (ASA Physical Status 1 and 2; aged 1–10 yrs) were assigned randomly in a prospective, blinded fashion to receive either midazolam 0.5 mg·kg⁻¹ (maximum 10 mg) or placebo. Behaviour assessments were made prior to medication, during induction of anaesthesia and 15 min following arrival to recovery room. The baseline behavioural evaluation scores were not significantly different. The children receiving midazolam cried significantly less during induction (P≤0.02). At one week follow-up, eight of 35 subjects receiving placebo had experienced adverse behaviour changes (nightmares, night terrors, food rejection, anxiety, negativism); 19 of 35 of the midazolam group experienced these changes (P≤0.02). At four week follow-up, most behaviour changes had resolved. Children given preoperative oral midazolam were less likely to cry and fight while being anaesthetized, and preoperative sedation was associated with increased incidence of adverse postoperative behaviour changes.     

Oral transmucosal midazolam premedication for preschool children

PURPOSE: To evaluate the acceptance and effectiveness of 0.2 mg x kg(-1) of oral transmucosal midazolam as a premedicant in infants and preschool children. METHOD: In a randomized, prospective double-blind placebo controlled study, 44 healthy children, between the ages of eight months to six years, presenting for elective surgery were divided in two groups. The medicated group received 0.2 mg x kg(-1) of injectable midazolam mixed with an equal volume of strawberry syrup and the placebo group received plain syrup 0.08 ml x kg(-1). Medications were placed on the anterosuperior aspect of the child's tongue in 3-5 aliquots of 0.2-0.4 ml. A blinded observer assessed the acceptance of the medication by willingness to open the mouth for the next aliquot and the efficacy of the medication was assessed by ease of separation from the parent. RESULTS: Ninety-six percent of the children in the placebo group and 95% in the midazolam group willingly accepted the medication. Separation of children from parents was successful in 95% of the medicated children compared with 59% in the placebo group (P = 0.006). CONCLUSION: Oral midazolam in thick strawberry syrup, administered in small aliquots via the oral transmucosal route was well accepted and proved to be an effective premedicant in infants and preschool children.     

Amnesic effect of oral midazolam as premedication in children]

We evaluated the sedative and amnesic effects of oral midazolam as premedication in children. Sixteen children, aged 4-12 yr, undergoing elective minor surgery were divided into 2 groups. One group received midazolam 0.5 mg.kg-1 with atropine 0.03 mg.kg-1 orally. The other control group received only atropine 0.03 mg.kg-1. There was no significant difference in the sedative scale at induction between the 2 groups. Doll-recall was used to assess the amnesic effects. In the midazolam group, 75% of the children forgot dolls they had seen on entering the operating room. Midazolam produced significant anterograde amnesia but no retrograde amnesia. This result suggests that children who received midazolam as premedication forget unpleasant memories at induction and their postoperative emotional responses are least influenced by their memories. We conclude that oral midazolam 0.5 mg.kg-1 is an effective preanesthetic medication in children.     

Comparison of intramuscular and intranasal premedication with midazolam in children

The study involved 40 children ASA I to II type who were randomly divided into two groups of 20 patients with comparable age and sex profile. Premedication consisting of 0.2 mg/kg of midazolam (Dormicum, Roche) and 0.015 mg/kg of atropine was administered 30 to 40 min before surgical intervention by intramuscular way in one group and by intranasal in the other one. In the operating room a peripheral vein was cannulated and general anesthesia was induced with thiopental sodium and succinylcholine. Arterial blood oxygen saturation, heart rate, arterial blood pressure and respiratory rate were measured at baseline, beginning of sedation (closing eyes), and arrival at the operating room. The time at the onset of sedation, the degree of sedation at the operating room, and the reaction to the venopuncture were also measured. In both groups of patients heart rate and systolic arterial blood pressure measured at the arrival to the operating room were significantly higher than those recorded at baseline and at the onset of sedation. Diastolic blood pressure in patients with intranasal premedication increased on arrival to the operating room with respect to the sedation values. Arterial oxygen saturation significantly decreased from the baseline values in both groups at the onset of sedation and on arrival at the operating room. There were no significant changes in respiratory rate. None of the alterations had clinical consequences. There were no significant differences in the onset of sedation (12.42 +/- 4.07 min in the intramuscular group and 15.26 +/- 7.99 min in the intranasal administration), degree of sedation and response to venopunction in either group.(ABSTRACT TRUNCATED AT 250 WORDS)     

Sublingual midazolam premedication in children: a dose response study

The purpose of this study was to evaluate various doses of sublingual midazolam premedication in children. In our prospective, double-blind, placebo-controlled trial, children (n=102, age range 12 to 129 months) scheduled for day surgery were randomized to receive either midazolam in one of three doses (0.25, 0.5, or 0.75 mg·kg^?1) or placebo. Injectable midazolam was mixed with a thick grape syrup and placed under the tongue; the patient was asked to hold it as long as possible before swallowing. Children readily accepted the mixture. Analysing all patients randomized, none of the children receiving placebo vs 28% receiving 0.25 mg·kg^?1 (P=0.02), 52% receiving 0.5 mg·kg^?1 (P<0.001), and 64% receiving 0.75 mg·kg^?1 (P<0.001) of midazolam showed satisfactory sedation (drowsy) at 15 min after administration. Children receiving the two higher doses of midazolam (0.5 and 0.75 mg·kg^?1) accepted mask induction willingly, while the group receiving 0.25 mg·kg^?1 resembled the placebo group (P<0.05).     

Oral midazolam in paediatric premedication

In a premedication study involving 135 children, aged 1-10 years, four regimens were investigated: (i) no premedication; (ii) oral trimeprazine tartrate 2 mg/kg, methadone 0.1 mg/kg, droperidol 0.15 mg/kg (TMD); (iii) intramuscular midazolam (Dormicum; Roche) 0.15 mg/kg; and (iv) oral midazolam 0.45 mg/kg. All premedications were given 60 minutes before a standard halothane anaesthetic. No impairment of cardiovascular stability occurred but after premedication the mean oxygen saturation decreased by 1.6% and 1.1%, respectively, in the intramuscular midazolam and TMD groups. Overall, children under 5 years of age behaved less satisfactorily in the holding room and at induction, than those over 5 years (P less than 0.01). Midazolam, intramuscularly and orally, produced more satisfactory behaviour than the other two regimens (P less than 0.05) and, combined with a 70% more rapid recovery than the TMD regimen (P less than 0.05), suggests that oral midazolam is a more effective paediatric premedication agent than placebo or TMD.     

The use of midazolam in premedication

Socio-psychological factors, such as increased anxiety in developed societies and cultures, and separation anxiety, particularly in children, justify the use of premedicants. In addition, the link between a central nervous "anxiety centre" and biochemical stress responses is blocked by an efficient anxiolytic. The elimination half-life of midazolam is longer in the elderly than in the young and in the obese than in the thin, which demands longer intervals between repeated doses in old and fat patients. The hypoxic ventilatory response is depressed in most patients and the ventilatory CO₂ response in patients with chronic pulmonary disorders, which justifies increased monitoring of O₂ saturations. It is important for the choice of dose and for estimating the duration of recovery time to know that midazolam is at least four times as potent as diazepam.     

Rectal premedication with midazolam in children. A comparative clinical study

Anesthetic premedication by injection is usually poorly accepted by children, especially those under 10 years of age. Less disturbing for the child is oral premedication, but this increases the risk of aspiration and must be administered 1.5-2 h before anesthetic induction. This double-blind study was performed in children to investigate the efficacy, acceptance, and general safety of midazolam given rectally. METHOD. Rectal premedication was administered to a total of 80 healthy children between 2 and 10 years of age undergoing elective operations. The children were divided randomly into two groups: group I received 0.4 mg/kg and group II 0.5 mg/kg midazolam with the addition of 0.015-0.02 mg/kg atropine. Premedication was carried out on the pediatric ward. The calculated dose was drawn from the ampule and diluted to 8-10 ml with distilled water. This dose was instilled immediately behind the anal sphincter using a suitable plastic applicator (Stanylan). The following parameters were recorded: immediate reaction to the rectal medication, sedative-hypnotic signs, and acceptance of the anesthetic mask. Heart rate and blood pressure were measured before premedication and before the induction of anesthesia. Observations were made for 5 h post-operatively. Any unusual side effects of the treatment were also noted. The existence of any anterograde amnesia was investigated in 20 children (10 in each group) between 6 and 10 years of age. RESULTS. There was no significant difference between the children allocated to the two groups with regard to age, body weight, sex, type of operation, and duration of anesthesia (Table 2). Of the total of 80 children, 66 (82.5%) accepted the rectal instillation well, 12 (15%) moderately well, and 2 (2.5%) poorly. Signs of respiratory depression or allergic reaction to midazolam were not observed in any case. The observations made before induction of anesthesia are presented in Table 3. The children in group II exhibited significantly greater (P less than 0.05) slurred speech than those in group I. A low incidence of hiccup was seen in both groups. Most of the children (27 in group I, 67.5%; 37 in group II, 92.5%: P less than 0.05) were delivered to the operating room lying down, whereas the others were sitting up in bed but showed no desire to get up. Between 10 and 55 min after the premedication, a total of 5 children (12.5%) in group I and 2 (5%) in group II were restless or crying on arrival in the induction room. Most, however, were quiet to tired/drowsy. The optimal sedative-hypnotic action was observed after 20-30 min (Fig. 1). At this time 21.7% of the children in group I were tired/drowsy, whereas 50% in group II were tired/drowsy and 9.1% were asleep but easy to arouse. This effect was significantly greater in group II (P less than 0.01). Acceptance of the mask was comparable in both groups (Table 4) and was tolerated well to very well by 92-97% of the children. (ABSTRACT TRUNCATED AT 400 WORDS)     

静脉输注右美托咪啶与咪达唑仑用于患儿术前用药效果的比较

目的 比较静脉输注右美托咪啶与咪达唑仑用于患儿术前用药的效果.方法 择期行普通外科或泌尿外科手术的患儿92例,年龄1～6岁,其中1～3岁及4～6岁儿童各46例,ASA分级Ⅰ或Ⅱ级,按年龄段分层后随机分为2组(n=46):咪达唑仑组(M组)和右美托咪啶组(D组).于麻醉诱导前约20 min由家长陪同进入麻醉准备室,分别于10 min内静脉输注咪达唑仑0.1 mg/kg或右美托咪啶1 μg/kg.采用异丙酚-罗库溴铵-瑞芬太尼行麻醉诱导,七氟醚-瑞芬太尼-罗库溴铵维持麻醉.于用药前(T1)、与家长分离(T2)和进入手术室(T3)时记录改良耶鲁术前焦虑评分(mYPAS)、镇静评分、HR、MAP、RR、SpO2.于T2,3时记录患儿进入睡眠状态(镇静评分4分)的发生情况.记录七氟醚呼气末浓度(CetSev)、瑞芬太尼输注速率、拔除喉罩时间、意识恢复时间、麻醉恢复室观察时间、苏醒期谵妄发生率、补救镇痛药使用率及不良反应的发生情况.结果 与T1时比较,两组T2,3时mYPAS评分降低、镇静评分升高,D组T3时HR及T2,3时MAP降低,M组T3时HR升高(P＜0.05);与M组比较,D组T2,3时镇静评分和睡眠发生率升高,T2时HR降低(P＜0.05),mYPAS评分、RR、MAP、SpO2、CetSev、瑞芬太尼输注速率、拔除喉罩时间、意识恢复时间、麻醉恢复室观察时间、苏醒期谵妄发生率、补救镇痛药使用率、不良反应发生率比较差异无统计学意义(P＞0.05).结论 静脉输注右美托咪啶用于患儿术前用药的镇静效果优于咪达唑仑,但对血流动力学的影响强于咪达唑仑,需注意血流动力学的变化.     

Reevaluation of rectal ketamine premedication in children: comparison with rectal midazolam

BACKGROUND: Results of previous studies of rectal ketamine as a pediatric premedication are clouded because of lack of dose-response relation, inappropriate time of assessing sedative effects, and previous administration or coadministration of benzodiazepines. Therefore, the authors reevaluated the efficacy of rectally administered ketamine in comparison with 1 mg/kg rectal midazolam. METHODS: Sixty-six infants and children (age, 7-61 months) who were American Society of Anesthesiologists physical status I and who were undergoing minor surgeries as in-patients were randomized to receive 5 mg/kg ketamine (n = 16), 7 mg/kg ketamine (n = 16), 10 mg/kg ketamine (n = 17), or 1 mg/kg midazolam (n = 17) via rectum. A blinded observer scored sedation 45 min and 15 min after administration of ketamine and midazolam, respectively, when children were separated from parent(s) for inhalational induction. All children underwent standardized general anesthesia with sevoflurane, nitrous oxide, and oxygen with endotracheal intubation. Blood pressure, heart rate, and oxyhemoglobin saturation were determined before, during, and after anesthesia. Postoperative recovery characteristics and incidence of adverse reactions were also assessed. RESULTS: Most children (88%) who received rectally 10 mg/kg ketamine or 1 mg/kg midazolam separated easily from their parents compared with those (31%) who received 7 or 5 mg/kg rectal ketamine (P < 0.05). Similarly, more children who received 10 mg/kg ketamine or 1 mg/kg midazolam underwent mask induction without struggling or crying compared with those who received 7 or 5 mg/kg ketamine (P < 0.05). There were no clinically significant changes in blood pressure, heart rate, and oxyhemoglobin saturation after administration of either drug. Immediately after surgery, more children receiving midazolam or 5 mg/kg ketamine were agitated compared with 7 or 10 mg/kg ketamine. Ketamine, 7 and 10 mg/kg, provided postoperative analgesia, but the largest dose of ketamine was associated with delayed emergence from general anesthesia. CONCLUSIONS: The results indicate that rectally administered ketamine alone produces dose-dependent sedative effects in children, when evaluated at its predicted peak plasma concentration. Ketamine, 10 mg/kg, has a delayed onset but is as effective as 1 mg/kg midazolam for sedating healthy children before general anesthesia. However, 10 mg/kg rectal ketamine is not recommended for brief surgeries because of prolonged postoperative sedation.     

Endocrine response to surgery in children after premedication with midazolam or papaveretum

The effect of two premedications on the sympatho-adrenal and endocrine stress-response to minor surgery under halothane anaesthesia was investigated in 16 children. One group (n = 9) was premedicated with midazolam, 0.1 mg kg-1, and atropine 0.2-0.4 mg i.m. The other group (n = 7) received papaveretum 0.4 mg kg-1 and hyoscine 0.008 mg kg-1 i.m. Plasma concentrations of catecholamines, ACTH and cortisol were measured during undisturbed anaesthesia, during surgery and 15 min post-operatively. There were no differences in catecholamine concentrations between the groups. Prior to surgery, plasma ACTH was significantly lower (P less than 0.05) in the papaveretum group. During surgery, plasma cortisol and plasma ACTH were significantly lower after papaveretum premedication. Post-operatively there were no differences. End-tidal CO2 concentrations were similar in the two groups. It was concluded that the endocrine stress-response immediately after induction of anaesthesia and during surgery was lower after papaveretum than after midazolam premedication.     

Oral ketamine or midazolam or low dose combination for premedication in children

This randomized controlled trial was designed to evaluate whether the combination of low dose oral midazolam (0.25 mg/kg) and low dose oral ketamine (3 mg/kg) provides better premedication than oral midazolam (0.5 mg/kg) or oral ketamine (6 mg/kg). Seventy-eight children of ASA physical status I or II scheduled for elective ophthalmic surgery were randomly divided into three groups and given premedication in the holding area 30 minutes before surgery. Two subjects from each group vomited the medication and were excluded, leaving 72 subjects for further analysis. The onset of sedation was earlier in the combination group than the other two groups. At 10 minutes after premedication 12.5% in the combination group had an acceptable sedation score compared with none in the other two groups. After 20 minutes 54% in the combination group had an acceptable sedation score, 21% in the midazolam group and 16% in the ketamine group (P<0.05). There were no significant differences in the parental separation score, response to induction and emergence score. The mean time for best parental separation score was significantly less in the combination group (19+/-8 min) than either the midazolam (28+/-7) or ketamine (29+/-7 min) groups (P<0.05). Recovery was earlier in the combination group, as the time required to reach a modified Aldrete score of 10 was significantly less in the combination group (22+/-5 min) than in the oral midazolam (36+/-11 min) or ketamine (38+/-8 min) groups. The incidence of excessive salivation was significantly higher in the ketamine alone group (P<0.05). In conclusion, the combination of oral ketamine (3 mg/kg) and midazolam (0.25 mg/kg) has minimal side effects and gives a faster onset and more rapid recovery than ketamine 6 mg/kg or midazolam 0.5 mg/kg for premedication in children.     

Midazolam premedication in children: a comparison of two oral dosage formulations on sedation score and plasma midazolam levels

We compared two available oral formulations of midazolam with respect to sedation score and plasma midazolam levels in pediatric surgical patients 2-10 yr old. The commercially available oral syrup was compared with a mixture of the IV midazolam preparation in Syrpalta syrup at an equivalent concentration of 2 mg/mL. ASA status I-II patients were randomly assigned to receive 0.5 mg/kg of either the commercial syrup (Group 1) or the prepared mixture (Group 2) as anesthetic premedication. Observer's Assessment of Alertness/Sedation scores were obtained by a blinded observer at 15 and 30 min after drug administration. Plasma midazolam levels were acquired exactly 45, 60, and 90 min after administration. Group 2 patients had a significantly lower median Observer's Assessment of Alertness/Sedation score (Group 1, 17; Group 2, 15) at 30 min (P < 0.03) and significantly higher mean plasma midazolam levels at all three acquisition times (mean +/- SD) (45 min: 63.1 +/- 23.9 ng/mL, Group 2; 43.4 +/- 19.6 ng/mL, Group 1; 60 min: 45.8 +/- 18.2 ng/mL, Group 2; 30.8 +/- 17.9 ng/mL, Group 1; 90 min: 28.9 +/- 12.6 ng/mL, Group 2; 21.0 +/- 8.9 ng/mL, Group 1) (P < 0.02). We conclude that IV midazolam mixed in Syrpalta syrup yields more reliable sedation and correspondingly higher plasma levels than an equivalent dose of the commercially formulated and marketed preparation.     

A comparison of oral transmucosal fentanyl and oral midazolam for premedication in children

Oral transmucosal fentanyl citrate (OTF) was compared with midazolam as a premedicant in a prospective, randomised, placebo-controlled, double-blind trial. Eighty children (ASA grade 1 or 2, aged 3-9 years) who presented for tonsillectomy were randomly allocated to receive either 2.5 ml OTF (15-20 microg.kg(-1)) in a lollipop format and 0.5 ml.kg(-1) placebo syrup, or midazolam syrup (0.5 mg.kg(-1)) and a placebo lollipop (2.5 ml). The acceptability of sedation, anxiety and compliance with anaesthetic induction were assessed. The children were given an 'emergence' score for their recovery. Analgesia requirements, the incidence of vomiting, itching and any behavioural changes were assessed for 6 h postoperatively. Oral transmucosal fentanyl citrate was as effective as midazolam in aiding compliance with anaesthesia, but is significantly better in its appeal to children (p < 0.001) and emergence (p < 0.001) characteristics. In conclusion, OTF may be particularly useful as a premedicant in paediatric practice.     

Oral high-dose midazolam premedication for infants and children undergoing cardiovascular surgery

BACKGROUND: The purpose of this study was to determine whether oral midazolam 1.5 mg x kg(-1) is a safe and effective alternative to standard-dose midazolam (0.5-1.0 mg x kg(-1)) premedication for infants and children with congenital heart disease. METHODS: A total of 193 infants and children (4 months to 2 years) undergoing cardiovascular surgery were studied. Each patient received 0.5, 1.0, or 1.5 mg x kg(-1) of oral midazolam. The level of sedation was assessed with a 5-point scale and vital signs were measured including blood pressure (BP), heart rate (HR) and oxyhaemoglobin saturation (SpO2) before and after the medication. RESULTS: Infants and children premedicated with oral midazolam 1.5 mg x kg(-1) were better sedated than those with standard-dose midazolam: 4% of infants and children given 1.5 mg x kg(-1) of midazolam became agitated compared with 14% given 1.0 mg x kg(-1) and 26% in those given 0.5 mg x kg(-1). Ninety percentage of infants and children given 1.5 mg x kg(-1) of midazolam achieved satisfactory sedation (calm, drowsy, or asleep) in 30 min, whereas 68% in those given 1.0 mg x kg(-1) and 35% in those given 0.5 mg x kg(-1). Midazolam 1.5 mg x kg(-1) did not cause any statistically significant decrease in BP, HR, or SpO2, although eight infants and children showed > or =20% drop in systolic BP and six infants and children showed >5% drop in SpO2. No 'spelling attacks', seizure-like activity, apnoea, nor laryngospasm were observed in any infants and children during and after the medication. CONCLUSIONS: Oral midazolam 1.5 mg x kg(-1) is excellent for preanaesthetic medication for infants and children undergoing cardiovascular surgery.     

Oral premedication with fentanyl may be a safe and effective alternative to oral midazolam

BACKGROUND AND OBJECTIVE: Although midazolam is commonly given orally to infants and small children for premedication, the taste is sometimes unacceptable even when mixed with syrup. We tested the efficacy and safety of oral fentanyl compared with oral midazolam in a randomized open-label study. METHODS: Fifty-one children, aged 12-107 months and weighing 10-25 kg, were randomly assigned to fentanyl or midazolam treatment groups. Midazolam (5 mg) or fentanyl (0.1 mg) was given orally from a small bottle with a small orifice 30 min before transfer to the preoperative holding room. The excitation-sedation conditions of the patients were assessed before and after general anaesthesia. RESULTS: The preoperative scores did not differ significantly between the two groups. No major complications were observed in either group. Postoperative vomiting occurred in 5 of 27 (18.5%) patients treated with oral fentanyl and in none of 24 of those treated with midazolam. CONCLUSIONS: Oral administration of fentanyl 30 min before entrance to the holding room for an operation from a bottle with a small orifice is a premedication option for children between 1 and 8 yr of age.