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.     

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.     

Oral midazolam premedication for paediatric day case patients

Forty-nine children having day-stay surgical procedures were randomly assigned to receive oral midazolam 0.75 mg·kg^?1 or placebo in a double blind fashion. The child's level of anxiety was assessed before premedication using parental, child and observer scales. The child and observer anxiety scores were repeated in the anaesthetic room. Most children presented for anaesthesia in a calm state, irrespective of whether they had received midazolam. Parents tended to overestimate their child's level of anxiety. Observer anxiety scores reliably predicted behaviour during induction of anaesthesia in the absence of a sedative. Observer scores decreased in the midazolam group (P<0.02), but not in the placebo group, children below six years having the greatest decrease with midazolam. The median time to discharge from hospital was delayed by 30 min in the midazolam group (P<0.01). Children do not require routine sedative premedication for day case procedures, but oral midazolam is useful in producing calm behaviour in those children with high observer anxiety scores.     

Oral premedication with midazolam in paediatric anaesthesia. Effects on sedation and gastric contents

The aim of this study was to assess oral premedication with midazolam in paediatric anaesthesia. Sedation, quality of induction, recovery time, acceptance and effects on gastric contents were analysed. This prospective, double blind, at random and controlled study was performed in 107 children, aged between three and ten years. They were divided into: group 1 (control, n=29), group 2 (placebo) receiving 5 ml of water in the preoperative stage (n=40), and group 3 (midazolam) with 0.75 mg·kg^-1 midazolam by mouth (n=38). Two children refused to take medication. In children aged five years or more (n=48) of groups 2 and 3, acceptance of premedication was evaluated. The midazolam group showed a better level of sedation as compared with the placebo (P<0.05). The recovery time was similar for the two groups. There were no statistically significant differences in gastric pH or residual volume among the three groups. It is concluded that midazolam given by mouth is an efficient and safe drug for premedication in paediatric anaesthesia.     

Oral midazolam is an effective premedication for children having day-stay anaesthesia.

The effect of oral premedication was studied in a double-blind, randomised trial of 200 children undergoing day-stay anaesthesia. Midazolam 0.25 mg/kg, midazolam 0.5 mg/kg, diazepam 0.5 mg/kg or a placebo was given orally one hour prior to anaesthesia. Patient state was assessed at nine stages, from administration of the premedication up to and including induction of anaesthesia, using a four-point behavioural scale. Patient state was also assessed postoperatively in the recovery area and the day-stay ward. There was no difference between the four groups until induction of anaesthesia. At this stage 82% of children were either asleep or awake and calm. Patients who received midazolam 0.5 mg/kg were more likely to be asleep or awake and calm at induction rather than other groups (P = 0.05). Children receiving midazolam 0.5 mg/kg or diazepam 0.5 mg/kg slept longest in the post anaesthetic recovery room (P less than 0.005), and spent most time there (P less than .005). There was no difference between groups in the length of time spent in the day-stay ward or in the number of overnight admissions. The study shows that a high proportion of unsedated children are calm at induction of anaesthesia and that oral midazolam is an effective premedication in children for day-stay anaesthesia.     

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 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.     

Oral premedication for paediatric ambulatory anaesthesia: a comparison of midazolam and ketamine

Canadian Journal of Anesthesia/Journal canadien d'anesthésie - To compare the clinical characteristics of two oral premedicants, midazolam and ketamine, 40 healthy children, one to six...     

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).     

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.     

Oral midazolam premedication in children: the minimum time interval for separation from parents

To determine the minimum time interval between oral midazolam (0.5 mg· kg^?1) premedication and separation from parents that ensures a smooth separation, 30 children were assigned randomly to one of three groups (ten children per group). The groups differed only in the time interval between administration of midazolam and separation from their parents: 10, 20 or 30 min. Heart rate, systolic blood pressure, and sedation and anxiolysis scores were assessed before midazolam premedication (baseline), at the time of separation from parents, and during the application of a face mask at the induction of anaesthesia. We found that heart rate and systolic blood pressure changes were similar for all three groups throughout the study period. Sedation scores at the time of separation from parents and on application of the mask for all three groups were greater than baseline values. Sedation scores at separation did not differ among the three groups. Anxiolysis values did not differ from baseline values at any time for all three groups. We conclude that children may be separated from their parents as early as ten minutes after receiving oral midazolam, 0.5 mg · kg^?1.     

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.     

Oral premedication in children

Preoperative and postoperative sedation, postoperative analgesia and vomiting were assessed following four different oral premedications in 143 children aged 1-10 years, weighing 10-30 kg, and undergoing elective adenotonsillectomy or inguinal surgery. Diazepam, diazepam combined with droperidol, trimeprazine and trimeprazine combined with droperidol were compared in a double-blind trial in conjunction with a standardised inhalational anaesthetic technique employing an intraoperative narcotic. Trimeprazine produced significantly more preoperative sedation (P less than 0.001) and was associated with enhanced postoperative analgesia (P less than 0.01). The incidence of postoperative vomiting was significantly less in the group receiving trimeprazine (P less than 0.001). The addition of droperidol to diazepam and trimeprazine only marginally improved the performance of those drugs but significantly prolonged postoperative recovery times. This was more marked when droperidol was combined with trimeprazine.     

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)     

Comparative evaluation of midazolam and ketamine with midazolam alone as oral premedication

BACKGROUND: Oral premedication with midazolam and ketamine is widely used in pediatric anesthesia to reduce emotional trauma and ensure smooth induction. However, various dosing regimens when used alone or in combination have variable efficacy and side effect profile. The aim of our study was to investigate and compare the efficacy of oral midazolam alone with a low-dose combination of oral midazolam and ketamine. METHODS: We performed a prospective randomized double-blind study in 100 children who were randomly allocated into two groups. Group M received 0.5 mg.kg(-1) oral midazolam and group MK received 0.25 mg.kg(-1) oral midazolam with 2.5 mg.kg(-1) oral ketamine. The preoperative sedation score, ease of parental separation and ease of mask acceptance were evaluated on a 4-point scale. The time to recovery from anesthesia and to achieve satisfactory Aldrete score was also noted. RESULTS: Uniform and acceptable sedation scores were seen in both the groups (group M 95.9%; group MK 97.96%), without any serious side effects. However, the combination offered significantly more children in an awake, calm and quiet state, who were easily separated from their parents (73.46% in MK vs 41% in group M). The induction scores were comparable between the groups. The recovery room characteristics and time to achieve satisfactory Aldrete score were also comparable between the two groups. CONCLUSIONS: Oral midazolam alone and a combination of midazolam with ketamine provide equally effective anxiolysis and separation characteristics. However, the combination provided more children in an awake, calm and quiet state who could be separated easily from parents.