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 transmucosal ketamine: an effective premedication in children

The oral cavity offers a simple, painless way of drug administration. For this reason, we used oral transmucosal ketamine (5–6 mg·kg⁻¹) for premedication in 15 children and compared it with intranasal ketamine (5–6 mg·kg⁻¹), placebo and intramuscular ketamine (5–6 mg·kg⁻¹). Oral transmucosal ketamine (OTK) provided effective sedation, facilitated i.v. line insertion and was accepted with pleasure by the patients (as lollipops). The lollipops produced a slight increase in gastric volumes but did not affect gastric pH. In conclusion OTK has been shown to be an effective, harmless preoperative medication in paediatric patients.     

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 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...     

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 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 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 in preadolescents and adolescents.

We sought to determine the influence of preoperative oral midazolam on 1) sedation score, 2) measures of anesthetic emergence, 3) recovery times, and 4) bispectral index (BIS) measurements during sevoflurane/N(2)O anesthesia in adolescent patients. Fifty ASA I and II patients 10-18 yr of age were enrolled in a prospective double-blinded study. Patients were randomized to receive either 20 mg of midazolam (M group) or midazolam vehicle (P group) as premedication. Before the induction, sedation scores and BIS values were determined in all patients. After inhaled induction and intubation, expired sevoflurane was stabilized at 3% in 60% N(2)O and the corresponding BIS (BIS I) recorded. Upon completion of surgery, sevoflurane was stabilized at 0.5% and the BIS (BIS E) again recorded. Plasma midazolam levels were measured at the time of BIS I and BIS E. There were no significant differences between groups in awakening time, sevoflurane/N(2)O awakening concentrations, time to postanesthesia care unit discharge, or BIS I and BIS E measurements. Sedation scores and preinduction BIS values were significantly lower in Group M than in Group P, although only 40% of midazolam-treated patients exhibited detectable sedation, with marked interindividual variability in achieved plasma midazolam levels. Detectable preoperative sedation was predictive of delayed emergence. IMPLICATIONS: We demonstrated a measurable sedative effect of oral midazolam in adolescents which correlated with simultaneous bispectral index (BIS) measurement. Considering the overall group, midazolam premedication did not affect intraoperative BIS, emergence times, or recovery times compared with placebo controls. Detectable preoperative sedation, and not merely midazolam administration, was predictive of prolonged emergence.     

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 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 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.     

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 ketamine premedication can prevent emergence agitation in children after desflurane anaesthesia

BACKGROUND: The purpose of the present study was to determine whether oral ketamine premedication affected the incidence of emergence agitation in children. METHODS: Thirty minutes before induction of anaesthesia, 80 children who were undergoing adenotonsillectomy with or without bilateral myringotomy and insertion of tubes received either ketamine 6 mg.kg(-1) per oral in group K or sour cherry juice alone in group C. Anaesthesia was maintained with desflurane. Emergence and recovery times were recorded. Tramadol was used for postoperative analgesia. Fentanyl (1 microg.kg(-1)) was administered for the treatment of emergence agitation or severe pain that still continued after tramadol administration. Postoperative behaviour was evaluated using a 5-point agitation scale. RESULTS: The incidence of emergence agitation was 56% in group C, and 18% in group K (P = 0.001). There was no significant difference with respect to emergence times except from time to eye opening that was significantly longer in group K (P < 0.0001). CONCLUSION: Oral ketamine premedication reduced the incidence of postanaesthesia emergence agitation in children without delaying recovery.     

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.     

Similar excitation after sevoflurane anaesthesia in young children given rectal morphine or midazolam as premedication

BACKGROUND: Sevoflurane is a rapid-acting volatile anaesthetic agent frequently used in paediatric anaesthesia despite transient postoperative symptoms of cerebral excitation, particularly in preschool children. This randomised and investigator-blinded study was designed to evaluate whether premedication with an opioid might reduce non-divertible postoperative excitation more than premedication with a benzodiazepine in preschool children anaesthetized with sevoflurane. METHODS: Ninety-two healthy two to six year-old children scheduled for nasal adenoidectomy were randomised to be given rectal atropine 0.02 mg kg(-1) together with either morphine 0.15 mg kg(-1) or midazolam 0.30 mg kg(-1) approximately 30 min before induction and maintenance of sevoflurane anaesthesia. The patient groups were compared pre- and postoperatively by repeated clinical assessments of cerebral excitation according to a modified Objective Pain Discomfort Scale, OPDS. RESULTS: There were no statistically significant postoperative differences in incidence, extent or duration of excitation between children given morphine or midazolam for premedication, whereas morphine was associated with more preoperative excitation than was midazolam. The study groups did not differ significantly with respect to age, weight, duration of surgery and anaesthesia, and time from tracheal extubation to arrival in and discharge from the postoperative ward. CONCLUSION: In this study morphine for premedication in young children anaesthetized with sevoflurane was associated with similar postoperative and higher preoperative OPDS scores compared with midazolam. These findings indicate that substitution of morphine for midazolam is no useful way of reducing clinical excitation after sevoflurane anaesthesia.