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Three anaesthetic premedication regimens have been compared by double-blind controlled trial in 158 patients undergoing day-case surgery for varicose veins or hernia. Atropine plus droperidol was superior to atropine plus diazepam or atropine alone in lessening nausea and vomiting and in reducing the need for postoperative analgesia.
Rectally administered midazolam (0.35 mg/kg) and diazepam (0.70 mg/kg) were compared with each other and with placebo for preanesthetic medication in children undergoing dental extractions. All rectal medications were very well accepted, but mask acceptance, improvement in anxiety, and sedation were best in the midazolam group. Improvement in anxiety and sedation were significantly better in the two drug groups than in those patients who had received placebo. Thirty minutes after rectal administration of midazolam, patients showed a decrease in both systolic and diastolic blood pressure and heart rate. Although these decreases differed significantly from the premedication values, they were probably of little clinical importance. Only minor adverse effects were observed in this study. Overall rectally administered midazolam appeared to be somewhat more efficacious than diazepam.
1. The purpose of the study was to confirm whether a subthreshold dose of CCK-4 would enhance the vulnerability of healthy subjects to a 35% carbon dioxide challenge. 2. 40 subjects, with no prior or present psychiatric disorder and in good physical health were challenged with a vital capacity breath of a 35% carbon dioxide 65% oxygen mixture, immediately after an intravenous injection of 10 microg CCK-4 or placebo, according to a random order, double blind, separate group design. 3. Subjects reported significantly less anxiety and panic symptoms upon carbon dioxide after premedication with CCK-4 than after placebo. 4. CCK-4 and carbon dioxide seem to inhibit rather than enhance each other's effects, possibly through an effect on different neurobiological systems.
To evaluate nasally administered midazolam 0.2 mg.kg-1 for preinduction of anaesthesia in paediatric patients the authors studied ASA 1 patients scheduled for elective surgery. Forty-five children, ages 3 to 126 months, were randomized in three groups: group D (n = 16) received diazepam 0.33 mg.kg-1 orally, group P (placebo) (n = 13) 0.04 ml.kg-1 normal saline via the nasal route; in group MDZ (n = 16) the children were given intranasal midazolam 0.3 mg.kg-1. The premedication was assessed on a 5-point sedation scale, modified to include the response to mask placement and the quality of the induction of general anaesthesia. The degree of sedation, heart rate, blood pressure, respiratory rate and oxygen saturation levels were recorded on the arrival in the operating room (0 min) and 3, 6, 9, 12 and 15 min (mask placement) after drug administration. With intranasal midazolam sedation was demonstrable at 6 min and was significant at 9 and 12 min. In this group all the children were calm or drowsy. The induction of anaesthesia was equivalent in group D and MDZ but easier than in those patients receiving normal saline. Vital signs did not change during the study period in any of the three groups. Intranasal midazolam was slightly more effective than oral diazepam. In children, it produces anxiolysis and sedation with rapid onset and is an attractive alternative to other routes for preanaesthetic medication.
Two groups of 27 individuals--12 males and 15 females each--were constituted thanks to the envelopes technique. The first group received 10 mg of midazolam and the second 15 mg of diazepam as an intramuscular premedication, 30 minutes before a surgical operation. Sedation of preoperatoire anxiety was relevant in 26 subjects after midazolam and in 11 after diazepam (p less than 0,001). Amnesia related to the different times of the operative procedure was more frequent in the midazolam group than in the diazepam group: 70 p. 100 versus 4 p. 100 for the arrival into the operating room (p less than 0,001) and 96 p. 100 versus 78 p. 100 for the recovery on operating table (p less than 0,05). The effects on blood pressure, pulse rate and respiratory rate are not significantly different in both groups: neither is the local and general tolerance. Considering its greater efficiency with a similar tolerance, midazolam as compared with diazepam can be regarded as a superior intramuscular premedicant.
The present study aimed to assess the pharmaco-clinical profile of infants premedicated with rectal midazolam. The results were compared with those of a reference drug, flunitrazepam. Infants undergoing minor surgery were divided into three groups: group A (n = 30), with a mean age of 15.8 +/- 13.2 months and a mean weight of 8.6 +/- 3.3 kg, receiving 0.33 mg X kg-1 flunitrazepam; group B (n = 15), with a mean age of 11.2 +/- 10.7 months and a mean weight of 9.3 +/- 3.1 kg, receiving 0.3 mg X kg-1 midazolam; and group C (n = 30), with a mean age of 15.5 +/- 9.1 months and a mean weight of 10.7 +/- 2.5 kg, receiving 0.4 mg X kg-1 midazolam. An aqueous solution of each drug was administered with atropine sulfate (0.02 mg X kg-1) 20 min prior to induction of anaesthesia. The drug was well tolerated in 84% of cases. Statistically significant haemodynamic changes consisted of: a 9 c X min-1 decrease in heart rate (p less than 0.05) and a 12 mmHg decrease in systolic and diastolic blood pressures (p less than 0.05) in group C; a 6 mmHg decrease in systolic blood pressure (p less than 0.05) in group B. The tranquilizer action was either excellent or good in 93% of groups B and C compared with only 40% in group A (p less than 0.001 in both cases). Somnolence was attained in 60% of group A, 26.6% of group B and 30% of group C. A mask was much better accepted in group C (86.6%) than in group B (66.6%; p less than 0.05) or in group A (36.6%; p less than 0.01). Therefore, midazolam given rectally at 0.4 mg X kg-1 was better than flunitrazepam, because of a greater therapeutic effect for an equivalent rate of side effects.
Eighty healthy children, between the ages of 2 and 7 years, who were to undergo oral surgical procedures under general anaesthesia, were allocated randomly to 4 groups. Three groups received rectal midazolam, and the other group a placebo (saline) as premedication 30 min prior to induction of anaesthesia. Group A children received midazolam 0.25 mg/kg, Group B 0.35 mg/kg and Group C 0.45 mg/kg. No statistically significant difference was found between the treatment groups as to the effect on systolic- (p = 0.6920) and diastolic (p = 0.8701) blood pressures, respiration (p = 0.0505) and pulse (p = 0.6192) rates at either pre- or post-sedation levels. However, the results indicate that levels of anxiolysis and sedation were significantly associated with midazolam dosage (p less than 0.0001).
We report two cases of overdoses of intramuscular midazolam used as a premedication. Both cases had no resedation or complications, but the accidents happened as a result of a resident and nurse's lack of experience with midazolam. The intramuscular doses, given at four times the normal quantity, fortunately caused no harm in our cases. However, the situations suggest that we should carefully check the dosage and review the correct procedures, even when using a drug that is considered to be familiar with most practitioners.
BACKGROUND AND OBJECTIVE: A need exists for a safe and effective oral preanaesthetic medication for use in children undergoing elective surgery. The study sought to define the dose of oral ketamine that would facilitate induction of anaesthesia without causing significant side-effects. METHODS: We studied 80 children undergoing elective surgery under general anaesthesia who received oral ketamine 4, 6 or 8 mg kg(-1) in a prospective, randomized, double-blind placebo controlled study. We compared the reaction to separation from parents, transport to the operating room, the response to intravenous cannula insertion and application of an anaesthetic facemask, the induction of anaesthesia and recovery from anaesthesia. RESULTS: In the group receiving ketamine 8 mg kg(-1), the children were significantly calmer than those of the other groups, and anaesthesia induction was more comfortable. Recovery from anaesthesia was longer in the group receiving ketamine 8 mg kg(-1) compared with the other groups, but no differences between the groups were observed after 2 h in the recovery room. CONCLUSIONS: It is concluded that oral ketamine 8 mg kg(-1) is an effective oral premedication in inpatient children undergoing elective surgery.
BACKGROUND AND OBJECTIVE: Unlike midazolam, melatonin premedication is not associated with cognitive impairment in adults despite its anxiolytic properties. The use of melatonin as a premedicant in children has not been reported. This randomized, double-blind, placebo-controlled study compared the perioperative effects of different doses of melatonin and midazolam in children. METHODS: Seven groups of children (n = 15 in each) were randomly assigned to receive one of the following premedicants. Midazolam 0.1, 0.25 or 0.5 mg kg(-1) orally, melatonin 0.1, 0.25 or 0.5 mg kg(-1) orally each mixed in 15 mg kg(-1) acetaminophen, or placebo only (15 mg kg(-1) acetaminophen). Anxiety and temperament were evaluated before and after administration of the study drug, on separation from parents and on the introduction of the anaesthesia mask. At week 2 postoperatively, the behaviour of the children was measured by the Post Hospitalization Behaviour Questionnaire. RESULTS: Melatonin or midazolam each in doses of 0.25 or 0.5 mg kg(-1) were equally effective as premedicants in alleviating separation anxiety and anxiety associated with the introduction of the anaesthesia mask. A trend was noted for midazolam to prolong recovery times as the dosage increased. The use of melatonin was associated with a lower incidence (P = 0.049) of excitement at 10 min postoperatively, and a lower incidence (P = 0.046) of sleep disturbance at week 2 postoperatively than that observed with midazolam and control groups. No postoperative excitement was noted in the melatonin groups at 20, 30 and 45 min. DISCUSSION: Melatonin was not only as effective as midazolam in alleviating preoperative anxiety in children, but it was also associated with a tendency towards faster recovery, lower incidence of excitement postoperatively and a lower incidence of sleep disturbance at week 2 postoperatively.
BACKGROUND: We evaluated the effect of oral clonidine on postoperative vomiting (POV) in children undergoing strabismus surgery. METHODS: Eighty ASA physical status I children aged 3-12 years were randomly assigned to one of two groups in a double-blinded manner. One hour before surgery, each patient in the clonidine group (n=40) received clonidine 4 micro g kg-1 in apple juice 0.2 ml kg-1, and each of the controls (n=40) received apple juice 0.2 ml kg-1 only. The protocol for general anesthesia was propofol-sevoflurane in N2O/O2. A paracetamol suppository was administered in each case to prevent postoperative pain. Patient responses during 0-48 h after anesthesia were recorded as complete (no POV, no antiemetic rescue required), retching, vomiting, or rescue antiemetic. RESULTS: There were no significant differences between the clonidine and control groups regarding the number of patients with complete response (21 vs. 18, respectively) retching (10 vs. 14, respectively), vomiting (19 vs. 22, respectively), or rescue antiemetic (9 vs. 12, respectively) during the first 48 h. CONCLUSION: Oral premedication with clonidine 4 micro g kg-1 did not reduce the rate of POV in the children undergoing strabismus surgery.
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 25 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.
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 < or = 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 < or = 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.
The metabolic and clinical responses to intravenously administered atropine+meperidine (pethidine), glycopyrrolate+meperidine, diazepam and placebo were examined in 76 healthy children. After atropine+meperidine and glycopyrrolate+meperidine administration, a significant antisialogogue effect, tachycardia and elevation in systolic blood pressure were observed. Diazepam decreased oxygen consumption (VO2) whereas atropine+meperidine increased both VO2 and energy expenditure (EE). The maximal effect of diazepam on VO2 was found 10 min after drug administration (mean difference from baseline -10.0%) and maximal effect of atropine+meperidine on VO2 and EE after 5 min (mean difference from baseline +6.0% and +3.3%, respectively). It is concluded that intravenous administration of meperidine with atropine or glycopyrrolate is followed by profound anticholinergic effects and such combinations do not appear to be suitable for clinical purposes. Although statistically significant, the alterations in VO2 and EE after diazepam and atropine+meperidine premedication can be considered clinically insignificant because they were of short duration and the measured changes represented only a fraction of fluctuation seen in normal values.
BACKGROUND: Clinical studies have provided conflicting conclusions about whether the frequency of emergence agitation is increased in children following sevoflurane anaesthesia. The purpose of the study was to determine a frequency and duration of agitation with halothane and sevoflurane anaesthesia and whether oxycodone premedication affected the incidence of emergence agitation in children. METHODS: We measured and compared halothane and sevoflurane recovery in 130 patients using a 5-point scale measuring emergence behaviour every 10 min during the first 60 min of recovery or until discharge. RESULTS: We used this 5-point scale to assess the presence or absence of emergence agitation and found a frequency of emergence agitation of more than 40% in children who received halothane and sevoflurane anaesthesia. CONCLUSIONS: Oxycodone reduced the frequency of agitation in children who received halothane, but not in the children who received sevoflurane anaesthesia.
This study was performed to determine the efficacy of an anticephalgic photoprotective premedicated mask in the treatment of migraine and/or tension-type headaches. There were 54 patients. They were given masks and numbered bottles of topical medication containing either salicin or placebo. The patients were instructed to apply the medication to their frontalis region in the event they should suffer a headache, apply a photoprotective mask, and lie down. Furthermore, they were instructed to take their usual oral or parenteral medications, if required, for relief of the headache. They subsequently filled out forms rating the degree of relief which they attributed to the topical medications and the masks using a 0 to 10 scale. They were also simply asked if this form of treatment helped or not. Seven of the 20 patients receiving placebo stated the medication and mask helped. The placebo group rated the treatment an average of 4.31 on a 0 to 10 scale. Twenty-eight of 34 patients receiving salicin stated it was effective. The salicin group rated it 7.42 on a 0 to 10 scale (P < 0.001). The majority of the salicin patients stated the duration of their headaches was significantly reduced, as was their need for analgesic and/or narcotic medications. This study demonstrates a significant difference between placebo and salicin in association with the photoprotective mask in treating migraines and/or tension-type headaches with associated frontalis pain and photophobia.
The degree of sedation and amnesia, subjective assessment of awakening and side effects after intravenous injection of 3-4 mg midazolam and 1 mg flumazenil or placebo were studied directly after colonoscopy, and on the first and the eight day. A total of 91 patients were studied; 45 patients were given flumazenil and 46 patients a placebo. Five minutes after injection of the test drugs all 45 patients given flumazenil but only 38 patients given the placebo were alert (p = 0.006). All three response criteria (for sedation, amnesia and subjective assessment of awakening) were fulfilled by 84.4% of the patients given flumazenil and 45.7% of the patients given the placebo (p = 0.0002). Thirty minutes after injection of the test drugs dizziness, nausea, and fatigue were found in 3 patients given flumazenil and in 10 patients given placebo. One day after colonoscopy 9 of 45 patients (20%) given midazolam and flumazenil complained of fatigue and 9 of 46 patients (19.5%) given midazolam and placebo. Eight days (+/- 1 day) later two patients in each group complained of headache, nausea and fatigue. No patient developed phlebitis at the injection site. Flumazenil seems to be a safe and efficient drug for reversing the sedative effect of midazolam, premedication after colonoscopy. However, resedation due to the effects of midazolam may occur. Flumazenil thus permits administration of a higher dose of midazolam without prolongation of the surveillance time. Improved exploitation of time, space and nursing resources is thus possible without jeopardizing patient safety, although caution is necessary since patients may not be fit to resume all normal activities.
AIM: The effects on cerebral function of premedication with the benzodiazepine flunitrazepam and with morphine were studied on the evening of the preoperative day (2 mg flunitrazepam p.o.) and 90 minutes before induction of anaesthesia (2 mg flunitrazepam plus 15 mg morphine i.m.). DESIGN: The EEG was analysed topographically (17 electrodes) and quantitatively. RESULTS: As a typical effect of benzodiazepines, increases in electrical activity in the frequency band beta-1 of the power spectrum were observed, and could be demonstrated 10 minutes after oral application, mainly in the frontal and central parts of the cortex. Increases in the powerbands delta and theta indicated induction of sleep approximately 15-20 minutes after application and were not looked upon as an effect of the benzodiazepine exclusively. These increases were noticed first in the central, occipital and temporal areas and after 30 minutes in the frontal parts of the cortex. Flunitrazepam plus morphine showed qualitatively similar but quantitatively less pronounced results. Topographical differences were similar to the results of an application of flunitrazepam alone. DISCUSSION: The results demonstrate the importance of a topographical as well as quantitative evaluation in studies on complex interactions of sedative or narcotic drugs and their clinical effects on cerebral function.