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A comparison of intramuscular and sublingual buprenorphine, intramuscular morphine and placebo as premedication.

Buprenorphine premedication by two routes, 0.4 mg sublingual and 0.3 mg intramuscular was compared double-blind, double-dummy with intramuscular morphine 10 mg and placebo in 74 patients undergoing elective total hip replacement. Anxiety, depressive mood, sedation, vital signs and side-effects were measured before surgery. All patients then received a standardised general anaesthetic using a muscle relaxant and ventilation. The effects of the premedication on the anaesthetic were assessed by a scoring system. Intra- and postoperative blood gases, plasma cortisol and glucose were measured and the 1 hour postoperative pain intensity, side-effects and sedation were assessed. No differences between the premedications were seen on any of the pre-, intra- or postoperative measurements, suggesting that even with adequate measurement sensitivity it is difficult to distinguish opiate from placebo premedication.

Administration, Oral↗

Effect of atropine-pethidine premedication on peripheral blood lymphocytes.

Phenothiazines, which are also employed for premedication, are known to have an inhibitory effect on the cell-mediated immunity. Therefore, the effect was studied in nine patients of the most commonly used atropine-pethidine premedication on the leucocyte and differential count, the number of T-and B-lymphocytes and the lymphocyte transformation by phytohaemagglutinin (PHA), Concanavalin A (ConA), pokeweed mitogen (PWM) and purified protein derivative of tuberculin (PPD) in cultures of separated lymphocytes and of whole blood. The premedication increased the proportion and absolute number of surface immunoglobulin-positive (B) lymphocytes in the peripheral blood and reduced the PHA and PPD responses in whole blood cultures. These vague changes in the immune response after premedication are of no importance in clinical work.

Adult↗

Premedication for day-case surgery: double-blind comparison of ketobemidone + dimethylaminodiphenylbuten (A-29) and morphine + scopolamine.

A double-blind comparison of the effect of Ketogan (ketobemidone and A-29, an anticholinergic and spasmolytic agent) and morphine + scopolamine as premedication was performed in 113 women admitted for abortion and in 114 women admitted for gynaecological dilatation and curettage. Anaesthesia was thiopentone and nitrous oxide and oxygen, occasionally supplemented with enflurane. It was found that 1 ml morphine + scopolamine (10 mg + 0.4 mg) was more sedative than 1 ml ketogan (ketobemidone 5 mg + A-29 25 mg). After ketogan there was less nausea and dryness of the mouth before induction of anaesthesia than after morphine + scopolamine. Ketogan had the same tranquillizing effect but less hypnotic effect preoperatively than morphine + scopolamine. During the 3-h postoperative observation period the patients premedicated with ketogan woke up significantly sooner and had more pain than those given morphine + scopolamine. More patients required postoperative antiemetics in the ketogan-premedicated group than in the morphine + scopolamine-premedicated group.

Abortion, Legal↗

Premedication with midazolam in out-patient general anaesthesia. A comparison with morphine-scopolamine and placebo.

Strong premedication may prolong recovery and cause side-effects after short surgical procedures in general anaesthesia. To be operated without premedication may be unpleasant for the patient. Midazolam is a water-soluble benzodiazepine with rapid onset and short half-life. In a randomized study with 193 female patients, we compared the effects and side-effects of three different premedicants i.m.: midazolam, morphine-scopolamine (Mo-Scop) and placebo. Midazolam and Mo-Scop had an equal and significantly better effect than placebo on preoperative anxiety and alertness. Side-effects like nausea, dry mouth and prolonged recovery occurred significantly more often in the Mo-Scop than the midazolam or placebo groups. The midazolam-premedicated patients had significantly more amnesia compared with the other two groups. Only 3% of the patients would prefer no medication before anaesthesia, whereas 80% would prefer a combination of an anxiolytic and hypnotic premedication. Sixty-three percent of the patients would prefer a premedicant administered by injection. The results indicate that midazolam i.m. is an effective premedicant, with few side-effects, for short procedures in general anaesthesia.

Adult↗

Premedication before elective breast surgery, a comparison between ketobemidone and midazolam.

One hundred female patients scheduled for elective breast surgery (mean age 60 +/- 11 years were randomly assigned to receive one of two premedications: ketobemidone (Ketogan) 1-1.5 ml or midazolam 4-5 mg, intramuscularly. The effects on preoperative anxiety and postoperative emetic sequelae were studied. All patients were anaesthetised with thiopentone, fentanyl and atracurium, and ventilated with a mixture of nitrous oxide in oxygen with supplementary isoflurane. Sixty-nine percent of the midazolam- and 50% of the ketobemidone-premedicated patients experienced a reduction in anxiety. Midazolam was found to be more effective than ketobemidone in reducing anxiety among more tense patients--those with a VAS grading before premedication of 2 or more (P less than 0.05). Midazolam-premedicated patients were also assessed by observers as being more relaxed (P less than 0.05). No difference was seen in the frequency of emetic sequelae: 20 patients in the midazolam group and 14 patients in the ketobemidone group vomited once or more during the 24-h observation period. There was no difference between the two groups in time until an analgetic was required. In conclusion, midazolam seemed more effective in reducing preoperative anxiety than ketobemidone without any negative effects on postoperative emesis or time until an analgetic was required.

Aged↗

Oral premedication one hour before minor gynaecological surgery--does it have any effect? A comparison between ketobemidone, lorazepam, propranolol and placebo.

The purpose of the present study was to compare the effects of oral premedication with ketobemidone 5 mg, lorazepam 1 mg, propranolol 40 mg or placebo, given about an hour prior to anaesthesia, in a prospective randomized double-blind fashion. One hundred and twenty ASA I female patients scheduled for elective laparoscopy were randomly prescribed one of the study drugs. Patient evaluation of anxiety, nurse evaluation of premedication, induction and postoperative course were studied. Ninety-three of the 120 patients (78%) experienced no change or a decrease in anxiety, regardless of type of active drug or placebo administered. Eighty-eight of the patients (73%) were considered adequately premedicated by the nurse observer, with no differences between the groups. Pre induction pulse rate, blood pressure and amount of induction agent needed was also similar between the four groups of patients. No major differences could be seen during the postoperative course. We found no major effects of any of the active drugs studied compared to placebo. Routine use of small doses of oral premedication one hour before elective surgery among low anxiety patients could probably be omitted.

Administration, Oral↗

Clonidine vs. midazolam as premedication in children undergoing adeno-tonsillectomy: a prospective, randomized, controlled clinical trial.

BACKGROUND: Clonidine administration in the setting of paediatric anaesthesia is associated with a number of desirable effects, e.g. preoperative sedation, analgesia and reduced anaesthetic requirements. The aim of the current study was to compare postoperative outcome variables using a prospective, randomized, double-blind design after premedication with clonidine or midazolam. METHODS: One hundred paediatric ASA physical status 1 patients (age 1-11 year) scheduled for adeno-tonsillectomy were assigned to receive rectal premedication with midazolam (300 microg kg(-1) and atropine 40 microg kg(-1); group M, n = 52) or clonidine (5 microg kg(-1 and) atropine 40 microg kg(-1); group C, n = 48) prior to a standardized sevoflurane anaesthetic. The incidence of immediate postoperative pain (0-2 h), as assessed by repeated Objective Pain Scale (OPS) scores, was chosen as the primary end-point of the study. Degree of sedation (modified Vancouver sedation scale 0-3), occurrence of postoperative vomiting (POV), and incidence of shivering and immediate postoperative confusion were registered as secondary end-points. After hospital discharge parents were instructed to continue the evaluation of pain, sedation, POV and sleep pattern during a 24-h period. Parents were also asked for their preference concerning the postoperative behaviour of their child (calm, sedated vs. alert, active). RESULTS: In the early postoperative period patients in the clonidine group had a significantly lower sum of 5 OPS scores (median = 8.0) compared to group M (median = 11.5) (P = 0.011). Administration of clonidine was also associated with a slightly higher sum of sedation scores (median = 13) in the early postoperative period compared to children receiving midazolam (median = 12) (P < 0.001). No episode of shivering was observed in the clonidine group but was present in five of the patients in the midazolam group (P = 0.057). In younger children (< 5 years) the incidence of postoperative confusion was lower in the clonidine group (P = 0.001). No difference in the frequencies of POV incidences, degree of postoperative pain, need for analgesics, or sleep pattern during the first 24 postoperative hours could be observed between the groups according to the parental evaluation. Children premedicated with clonidine were more calm and sedated compared to children in the midazolam group (P = 0.024) as judged by their parents. A significant majority of parents (75%; P < 0.001) preferred a calm and sedated child during the first postoperative 24-h period. CONCLUSION: Rectal premedication with clonidine was associated with a significant reduction of pain in the early postoperative period compared to midazolam and was also associated with moderately increased sedation during the first 24 postoperative hours. The sedative effect of clonidine is in agreement with the unambiguous finding of a parental preference for a calm and sedated child during the first 24 postoperative hours.

Adenoidectomy↗

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.

Adenoidectomy↗

Paradoxical reaction following intravenous midazolam premedication in pediatric patients - a randomized placebo controlled trial of ketamine for rapid tranquilization.

BACKGROUND: Paradoxical reactions to benzodiazepines include restlessness, violent behavior, physical assault, act of self-injury and need for restraints. These may occur at variable times after administration. This study was designed to determine the incidence of paradoxical reactions following intravenous midazolam premedication in pediatric patients and to compare the efficacy of extra doses of midazolam with low-dose intravenous ketamine to rapidly tranquillize them. METHODS: A total of 706 ASA I, II children scheduled for elective surgery were given intravenous midazolam premedication. Children who developed a paradoxical reaction were randomly divided into three equal groups to receive: (i) extra midazolam, (ii) ketamine, or (iii) placebo as the test drug for treatment of paradoxical reaction. Ease of rapid tranquillization and need for a rescue tranquillizer (i.e. ketamine; irrespective of patient group) were compared among the three groups. RESULTS: Twenty-four (3.4%) children developed paradoxical reaction after midazolam premedication. Those who received ketamine as the test drug responded rapidly to ketamine. But the responses of the other two groups to their test drug were poor and the majority of them required ketamine as rescue tranquillizer (six in midazolam, seven in placebo, but no patient in the ketamine group; P < 0.05). CONCLUSIONS: The results of this study demonstrate that ketamine is an effective drug for the treatment of paradoxical reaction following intravenous midazolam premedication. The exact mechanisms of these reactions and how it is aborted by ketamine are not clear.

Analgesics↗

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.

Adjuvants, Anesthesia↗

[Oral dormicum premedication of children in day surgery].

Thirty-four patients aged 5-14 years were observed, divided into age groups OF 5-8 and 8-14 years. Cardiovascular function was evaluated by central hemodynamic parameters and cardiointervalography. Changes in external respiration parameters were studied. The efficacy of premedication was assessed by objective parameters and by clinical signs. Each patient was examined 4 times at the following stages: 1) before premedication; 2) at the 10th min; 3) at the 20th min; and 4) at the 30th min. Oral premedication with dormicum in a dose of 0.5 mg/kg did not affect heart rate or arterial pressure. By the 20th min it notably decreased total peripheral resistance, significantly decreased the respiratory volume, increased respiration rate, and decreased sympathetic tone in younger children. In older children the premedication virtually did not affect total peripheral resistance and facilitated heart work, increased the respiratory volume, rarefied the respiratory rate, and did not affect the autonomic regulation balance. Younger children fell asleep without excitation or negativism; 35.2% developed psychomotor reactions. In older group the effect was good in 71.1% children, the rest had "apparitions" starting from the 17th min: doubling of the staff's faces, white spiders, or white moths.

Administration, Oral↗

[Premedication in ambulatory surgery].

UNLABELLED: A substantive amendment to this systematic review was last made on 3 January 2000. Cochrane reviews are regularly checked and updated if necessary. OBJECTIVES: To assess the effect of anxiolytic remedication on time to discharge in adult patients undergoing day case surgery under general anaesthesia. SEARCH STRATEGY: Trials were identified by computerised searches of the Cochrane Controlled Trials Register, MEDLINE, EMBASE, by checking the reference lists of trials and review articles, by handsearching three main anaesthesia journals and by contacting five researchers active in the field and the Product Information departments of the manufactures of five commonly used premedicants. SELECTION CRITERIA: All randomised controlled trials comparing an anxiolytic drug(s) with placebo before general anaesthesia in adult day case surgical patients. DATA COLLECTION & ANALYSIS: We collected data on anaesthetic drugs used, results of tests of psychomotor function where these were used to assess residual effect of premedication, and on times from end of anaesthesia to ability to walk unaided or readiness for discharge from hospital. Formal statistical synthesis of individual trials was not performed in view of the variety of drugs studied. MAIN RESULTS: Searching identified twenty-nine reports; fourteen studies, with data from a total of 1263 patients, were considered eligible for analysis. Only two studies specifically addressed the discharge question; both found no delay in premedicated patients. Three other studies used clinical criteria to assess fitness for discharge, though times were not given. Again, there was no difference from placebo. Four studies used both clinical measures and tests of psychomotor function as tests of recovery from anaesthesia. In none of these studies did the premedication appear to delay discharge, although performance on tests of psychomotor function was sometimes still impaired. Of the four studies which used tests of psychomotor function to assess recovery, three showed impaired recovery (after midazolam 7.5 mg, midazolam 15 mg or diazepam 15 mg) which might possibly interfere with discharge from hospital. REVIEWERS' CONCLUSIONS: We have found no evidence of a difference in time to discharge from hospital in patients who received anxiolytic premedication. However, in view of the age and variety of anaesthetic techniques used, inferences for current day-case practice should be made with caution.

Ambulatory Surgical Procedures↗

[Study of midazolam for premedication in oral and maxillofacial surgery].

OBJECTIVE: To study the effects of midazolam for premedication in oral-maxillofacial surgery. METHODS: 60 patients were selected and divided into 3 groups equally with 20 cases in each group. Different drugs were used for premedication. Group received midazolam 0.06 mg/kg, group received diazepam 0.12 mg/kg, group received luminal 3 mg/kg, Intramuscular injections of drugs were finished before 30 minutes of anesthesia. The sedative and anxiolytic effects, the changes of circulation and respiration and the side effects were evaluated. RESULTS: In group, BIS (bispectral analysis of electroencephalogram) decreased obviously and Ramsay score increased significantly 5 minutes after drug administration, AVAT(Anxiety visual analog test) and SAI(State anxiety inventory) decreased obviously 30 minutes after administration drug (P < 0.05). But no significant changes in the other groups (P > 0.05). There were no remarkable changes of circulation and respiration in the three groups. No severe side effects were observed after premedication. CONCLUSION: The premedication of using midazolam has good sedative and anxiolytic effects and few side effects.

Adolescent↗

[Peripheral oxygen saturation during dental surgery with and without premedication].

83 adults undergoing dental surgical procedures in local anesthesia were monitored continuously with a pulse oximeter for hypoxemia. 30 patients received as premedication either a combination of a neuroleptic drug and an opiate or a benzodiazepine. There was a drop in the oxygen saturation in 80% of the patients with premedication but only in 66% of the patients without. There were statistical highly significant more periods of hypoxemia in patients with premedication compared to the others. (1548 periods versus 659 periods p less than 0.001). The kind of premedication/sedation does not influence the number of hypoxic episodes. We conclude that especially patients with premedication should only be treated by surgeons with sufficient clinical experience in coping with emergency situations.

Anesthesia, Dental↗

Midazolam and amnesia in pediatric premedication.

One hundred and twenty-eight children aged three to ten years, were studied to determine the effect of premedication on amnesia for the preanesthetic period. Four comparable groups were used: A control group, no premedication; oral trimeprazine tartrate 2 mg/kg, methadone 0.1 mg/kg plus droperidol 0.15 mg/kg (T.M.D.); oral midazolam 0.45 mg/kg; intramuscular midazolam 0.15 mg/kg. Amnesia was tested for four pictorial facts, and for induction of anesthesia. For pictorial facts, both routes of midazolam administration gave a sixty percent incidence of amnesia compared with sixteen percent in the control group (p less than 0.001). The T.M.D. premedication provided a forty-three percent incidence, also better than the control group (p less than 0.05). Induction was remembered by fifty percent of the midazolam children compared with sixty-six percent of the T.M.D. group (p greater than 0.05) and eight-one percent of the control group (p less than 0.05). The potential advantages of amnesia in pediatric premedication are discussed.

Administration, Oral↗

[The influence of premedication with dipotassium chlorazepate on preoperative stress and postoperative pain].

Despite the fact that dipotassium chlorazepate (DC) is widely used for oral premedication there are few studies demonstrating the effects of this drug reliably in the preoperative patient. Therefore, we investigated the influence of DC on preoperative sleep, stress and postoperative pain, which is presumed to be influenced by the long-acting anxiolytic property of DC compared to a placebo in a double-blind study. Sixty patients undergoing dental surgery received either 20 mg DC or a placebo in the evening and at 7 o'clock in the morning before the operation, both administered orally. The quality of sleep, preoperative anxiety, depression, asthenia and postoperative pain were assessed, using nominal and visual analogous scales. The degree of sedation and the quality of premedication were assessed by the anesthesiologist. Blood pressure and heart rate were registered and interpreted as physiological stress parameters. The 2 groups were comparable with respect to the anthropometric data as well as the initial values of all other parameters. Patients receiving DC reported significantly better quality of sleep in the night before the operation. There was no difference between DC and P concerning preoperative stress either emotionally or physiologically. The postoperative pain intensity did not differ between the two groups. The quality of premedication, assessed by the observer, was comparable in both groups. Whereas DC has a positive effect on the quality of sleep in preoperative patients, it does not influence the preoperative stress on the day of operation. This might be dose-dependent, but 20 mg is recommended for premedication.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗

[The amnesic effects of midazolam in premedication of children].

The aim of this study was to check local and general tolerance as well as anxiolytic and amnesic effects of midazolam intramuscular administration as a premedication in 4 to 10 years old children. A double blind, comparative study with a placebo was achieved, after drawing lots, in 40 children divided into two equal groups. Premedication consisted of either midazolam or injectable water administrated with a posology of 0.3 to 0.5 mg.kg-1 combined, in both cases, with atropine sulfate (0.015 mg.kg-1). Results confirmed good local and general tolerance. Also anterograde amnesia was found to be excellent: 17 children in the midazolam group did not remember a photograph shown after premedication, instead of only one in the placebo group. Anxiolytic effects, similar in both groups, cannot be considered owing to the too short interval of time from premedication to induction.

Anxiety↗

[Effect and side effects of oral morphine, lormetazepam and placebos as premedication].

In 60 patients undergoing a curettage in thiopentone induced inhalation anaesthesia with enflurane and N2O/O2 = 2:1, the effects of oral premedication (2 h before anaesthesia) with 30 mg morphine (MST 30) (n = 21), 1 mg lormetazepam (Noctamid) (n = 19) and placebo (n = 21) on psychological (anxiety, depression and asthenia), physiological (blood pressure, heart and respiratory rate) and pain parameters (visual analogue scale, analgesic consumption) were investigated. The study design was single blind, randomized. Before premedication the three groups did not differ in one parameter and so were comparable. MST 30 had a significantly better anxiolytic, Lormetazepam a significantly better antidepressive effect than the compared substance. There were no differences in blood pressure and heart rate. In contrast to lormetazepam and placebo after MST 30 there was no increase in the respiratory rate which can be explained by the anxiolytic stress reducing effect. There was no difference in peri- and intraoperative pain parameters, probably due to the type of surgery. Nausea and vomiting occurred more frequently after MST 30, but there was no significance. A higher rate was probably prevented by the application of transdermal scopolamine the day before surgery. The indication of analgesics (opiates) for premedication is discussed taking the controversy into account. The results of this study show that oral morphine (MST 30) has an anxiolytic effect, one of the most important effects a premedication should have. Further studies should investigate in which types of surgery the analgesic effect of MST 30 is peri- and intraoperatively relevant, so that advantages compared to e.g. Flunitrazepam, Midazolam or Lormetazepam in a higher dosage could be expected.

Administration, Oral↗