Oral clonidine pre-treatment and diazepam/meperidine sedation

Clonidine has recently been used as a pre-operative medication and sedative/anxiolytic drug. Its extended duration of action makes it suitable for longer procedures. In this randomized, crossover, placebo-controlled clinical trial, we characterized the effects of oral clonidine pre-treatment on intravenous diazepam/meperidine sedation using the bi-spectral index (BIS) in 13 participants. Clonidine significantly increased the numbers of BIS-depressed readings and percent memory loss during sedation, while reducing total diazepam and post-operative analgesic dosages by 44% and 55%, respectively. Systolic, diastolic, and mean arterial blood pressures, as well as pulse rates, were reduced. Respiratory rate, oxygen saturation, end-tidal CO(2), and recovery from sedation were unchanged. Participants, surgeons, and sedationists preferred clonidine over the placebo. Clonidine pre-treatment increased and prolonged sedation and amnesia and stabilized vital signs while significantly decreasing diazepam and post-operative analgesic usage. These results suggest that pre-operative clonidine administration could be a useful supplement to intravenous sedation for dental procedures of long duration.     

Intravenous or rectal diazepam for outpatient sedation in minor oral surgery

In a randomized cross-over study on sedation in outpatient oral surgery, intravenous and rectal administration of diazepam were compared. The mean dose for intravenous diazepam was 0.22 mg X kg-1 (range 0.15-0.38) and for rectal diazepam 0.58 mg X kg-1 (range 0.50-0.71). The determining factors for the patients' preference for sedation method, apprehension, effect produced by the sedative, recovery from sedation and the postoperative course were studied. The patients preferred the session in which they experienced stronger effect, regardless of the route of administration. Patient preference for sedation method did not differ when optimal dose regimens were used, and a preset dose of 10 mg rectal diazepam did not produce the desired effect. Apprehension was significantly higher prior to and during the first operation than the second operation, and all patients recovered from sedation within 2 1/2 hours after the administration.     

Double-blind comparison of nalbuphine and meperidine in combination with diazepam for intravenous conscious sedation in oral surgery outpatients

Nalbuphine and meperidine were compared as analgesic components of intravenous conscious sedation in a double-blind, prospective trial of 47 patients undergoing elective oral surgery. Subjects were evaluated for pain intensity, pain relief, anxiety, sedation, recall, and vital signs at systematic observation points intraoperatively and postoperatively. At the conclusion of surgery 83% of patients who had received nalbuphine and 86% of patients treated with meperidine indicated complete pain relief. One observed adverse reaction was attributed to meperidine and another to the sedative component diazepam. No statistically significant differences were observed between nalbuphine and meperidine treatments.     

The actual dose delivery from a diazepam enema differs depending on the patients position during administration

In a randomized single-blind cross-over study on 14 volunteers the relation between dose, effect and serum concentration was studied when diazepam in solution was administered in a dose of 0.5 mg/kg bodyweight rectally with the volunteer placed either laterally or prone. When lying prone the delivered diazepam dose was on average 24% higher compared to in the lateral position. The difference in delivered dose affected sedation as well as serum concentration but did not prolong recovery time. At the time of clinical recovery, the serum concentration was still at a very high level. Oxygen (p02) and carbon dioxide (pCO2) tensions were monitored transcutaneously in 9 subjects and were unaffected by the sedative level. The study suggests that when diazepam enemas similar to the ones used here, they should be administered with the patient in a prone position.     

Prolonged recovery after intravenous diazepam

Prolonged recovery from intravenous diazepam after the day of administration has been examined in 2,468 consecutive patients who underwent oral surgery and general dentistry. Patients ranged in age from 2 to 94 years and received a mean diazepam dose of 19 mg, either by itself or with small amounts of methohexital sodium. Recovery was assessed by use of a questionnaire, and the answers were related to sexual gender, age, weight, dosage, procedure, duration, level of apprehension, and results of the sedation.     

Comparison of sedation,amnesia, and patient comfort produced by intravenous and rectal diazepam

In a cross-over study, intravenous diazepam was compared with rectal diazepam for sedation in outpatient oral surgery. Fifty-four operations were performed on 27 patients. Recovery from sedation, experience during the postoperative course, amnesia, estimation of the sedative effect, and patient preference of method of sedation were studied. The recovery times of the sedation methods did not differ. Sedative effects after the first operation were estimated as good by 87% of patients given intravenous sedation and by 75% of those given rectal sedation. However, there was a significant relationship between the subjective experience of stronger sedative effect and preference of sedation method that favored the intravenous technique. The degree of amnesia was significantly higher during intravenous sedation, but a high degree of amnesia was not related to patients' preference for a sedation method. Neither sedation method produced any local side effects.     

A comparison of chloral hydrate and diazepam sedation in young children

The purpose of this study was to compare a high and low dose of diazepam with chloral hydrate in the sedation of young children. Thirty healthy children between the ages of 20 and 48 months, with a mean age of 33.5 months, participated in the study. All children exhibited negative behavior during a screening visit and required at least two restorative appointments with the use of sedation. A dose of either 0.3 mg/kg or 0.6 mg/kg of diazepam at one visit and 50 mg/kg of chloral hydrate at another visit was administered in a double-blind manner. All children were restrained in a Papoose Board with auxiliary head restraint and received 50% nitrous oxide/oxygen during treatment. The degree of sleep, body movement, crying, pulse rate, respiratory rate, and blood oxygen saturation were monitored before and during the operative procedures. Vital signs remained essentially unchanged during treatment, except for transitory elevations of the pulse during periods of stimulation. There were no statistically significant differences among the three drug regimens with regard to movement and crying. Significantly more patients who received chloral hydrate were asleep than when either dose of diazepam was given during the first 60 min of treatment. The only side effect found was vomiting in one patient with both chloral hydrate and diazepam. It is concluded that the sedative effects of chloral hydrate and diazepam are similar when young children are sedated for dental treatment. The use of diazepam might be more advantageous because chloral hydrate produces more sleep during the first hour of treatment.     

Intravenous diazepam in dentistry: operating conditions in a controlled clinical trial

A controlled clinical trial of diazepam in patients undergoing conservative dentistry or oral surgery showed a reduction in cavity preparation time without deterioration in operating conditions. Patients responded enthusiastically to intravenous sedation with diazepam.     

A comparative study of intravenous diazepam and midazolam for oral surgery

Intravenous diazepam was compared with intravenous midazolam for conscious sedation in a single-blind study of 50 Hong Kong Chinese patients acting as their own controls. Verrill's sign was used as the end-point of sedation, and bilateral, similarly impacted lower third molars served as the surgical model. The drugs produced comparable levels of sedation, stable vital signs, and good operating conditions in all patients. Midazolam had numerous advantages over diazepam: more rapid onset of sedation, less pain during injection, profound anterograde amnesia, and fewer postoperative complications. The incidence of thrombophlebitis was low with both drugs and appears to be so in Chinese in general. A significant majority of the patients preferred sedation to other techniques and midazolam to diazepam.     

An evaluation of the amnesic effects of diazepam sedation

Twenty subjects, 13 female and 7 male, aged 16 to 37 years, were studied to determine the effects on memory of intravenous sedation with diazepam (Valium). Three tests were performed: 1) the Weschler Logical Memory Scale; 2) memory of three geometric shapes; and 3) memory of three objects presented in a drawing. Logical memory items were presented before and after sedation; other tests were presented after sedation. Anterograde amnesia was produced by diazepam sedation. No retrograde amnesia was observed. A significant drug effect was found between the pre-drug and post-drug retention intervals (T+ = 2; P less than 0.005). Post-drug recognition scores were found to be approximately 42% of pre-drug recognition scores. The anterograde amnesia produced with diazepam was probably due to decreased arousal of the subject, and decreased attention to rehearsal of short-term memory stimuli, resulting in a lack of storage of the stimuli.     

Amnesia,pain experience,and patient satisfaction after sedation with intravenous diazepam

Recovery time, the effect of sedation or amnesia on postoperative pain, and patients' opinions of the sedation were studied. Forty operations were performed on 20 patients. Each patient had four impacted third molars removed in two sessions, one in which a new emulsion form of diazepam (Diazemuls^®) was used, and one in which no sedation was used. The recovery from sedation was found to be very individual and not related to the dose administered, as assessed by a simple, easy-to-use method. There was no difference in postoperative pain between the sedated and unsedated groups, and we found no correlation between postoperative pain and amnesia. Eighty-five per cent of the patients preferred sedation during surgery, even though none of them had a preoperative indication for sedation.     

Assessment of stress during periodontal surgery with intravenous sedation and with local anesthesia only

Ten patients with moderate to advanced periodontal disease were subjected to two similar periodontal surgical procedures. Each patient received either intravenous conscious sedation with local anesthesia or local anesthesia only. The stress-reducing effects of a conscious sedation regimen consisting of pentobarbital, meperidine, and diazepam were evaluated in these patients. Stress was evaluated by monitoring changes in serum cortisol, human growth hormone, and vital signs. Blood samples were obtained at 15- to 30-minute intervals throughout each procedure and were evaluated for serum cortisol and growth hormone. The conscious sedation group had significantly lower serum cortisol levels and lower systolic blood pressure, indicating that the patients having periodontal surgery with conscious sedation experienced reduced stress. Physiologic stability was maintained for each patient, indicating that this conscious sedation regimen can be used to reduce measurable parameters of stress that patients develop during periodontal surgery.     

A double-blind comparison of nalbuphine and meperidine hydrochloride as intravenous analgesics in combination with diazepam for oral surgery outpatients

This study compared the analgesic efficacy, sedative, and amnesic properties, and side effects of nalbuphine versus meperidine as intravenous premedicants in combination with intravenous diazepam for the treatment of outpatients undergoing the removal of impacted third molars with alveolar nerve block anesthesia. Forty patients were evaluated in this double-blind crossover study. Nalbuphine was shown to have analgesic, sedative, and amnesic properties similar to meperidine. Nalbuphine, when compared to meperidine, produced significantly lower intraoperative systolic and diastolic blood pressures. Because of this cardiovascular stability, nalbuphine should be considered over meperidine for use in the cardiovascularly compromised patient undergoing oral surgery.     

Rectal sedation with diazepam or midazolam during extractions of traumatized primary incisors: a prospective, randomized, double-blind trial in Swedish children aged 1.5-3.5 years.

The aim of this study was to compare rectal sedation with diazepam and rectal sedation with midazolam with regard to sedative effect, treatment acceptance, and amnesia. Ninety children, 1.5-3.5 years of age, consecutively referred for extractions of traumatized primary incisors were randomly sedated with diazepam (0.7 mg/kg body weight) or midazolam (0.3 mg/kg body weight). The study design was randomized and double-blind. The level of sedation (state of mind) was assessed prior to and 10 and 60 min after administration of the drug by use of a behavioral scale (Wilton). The children's acceptance of procedures was assessed using another behavioral scale (Holst) during administration of the sedative, application of topical anesthesia, injection of a local anesthesia, and extraction. Amnesia was evaluated by the parents on the following day, with the child being asked standardized questions. Parental ratings of the child's and their own distress during and after treatment were made on a visual analog scale (VAS). No differences were found between the sedatives concerning level of sedation during treatment, acceptance of procedures, or amnesia. At discharge, 60 min after administration of the sedative, the children receiving diazepam were significantly more agitated (P=0.006). Parental rating on a VAS of the child's discomfort after treatment was significantly higher in the diazepam group (P=0.006). There was a tendency for children with poor acceptance of the rectal administration to display a more negative acceptance of the dental treatment. In conclusion, the present results, in combination with known pharmacological advantages, indicate that midazolam is preferable in outpatients when sedation is needed and amnesia is desirable.     

Butorphanol as a dental premedication in the mentally retarded

Seventy institutionalized severely and profoundly retarded patients were administered intramuscular butorphanol, 1.0 to 4.0 mg, for premedication prior to dental procedures. These patients had been refractory to previous combined chloral hydrate and diphenhydramine treatment. Clinical efficacy was categorized according to the extent that adjunctive restraints were required to accomplish the dental procedure. A total of 151 butorphanol trials were recorded. Butorphanol was observed to be clinically effective in 74.8% of the administrations and sedation was observed in 28.2% of the trials. Dosage titration increased efficacy to 85.0%. Contribution of concurrent central nervous system depressant medication to clinical efficacy and dose requirements lacked statistical significance; however, a strong trend (p = 0.068) was found in the medication-free group with higher dosage. Vomiting (2.6%) was the most frequent adverse effect observed. One patient had marked cardiorespiratory depression that was promptly reversed by intravenous naloxone. Two patients experienced mild hypotensive episodes immediately following injection, but they recovered uneventfully. Butorphanol was shown to be a safe and effective agent for dental premedication in this difficult patient population.     

Rectal sedation with diazepam or midazolam during extractions of traumatized primary incisors: a prospective,randomized, double-blind trial in Swedish children aged 1.5-3.5 years

The aim of this study was to compare rectal sedation with diazepam and rectal sedation with midazolam with regard to sedative effect, treatment acceptance, and amnesia. Ninety children, 1.5-3.5 years of age, consecutively referred for extractions of traumatized primary incisors were randomly sedated with diazepam (0.7 mg/kg body weight) or midazolam (0.3 mg/kg body weight). The study design was randomized and double-blind. The level of sedation (state of mind) was assessed prior to and 10 and 60 min after administration of the drug by use of a behavioral scale (Wilton). The children's acceptance of procedures was assessed using another behavioral scale (Holst) during administration of the sedative, application of topical anesthesia, injection of a local anesthesia, and extraction. Amnesia was evaluated by the parents on the following day, with the child being asked standardized questions. Parental ratings of the child's and their own distress during and after treatment were made on a visual analog scale (VAS). No differences were found between the sedatives concerning level of sedation during treatment, acceptance of procedures, or amnesia. At discharge, 60 min after administration of the sedative, the children receiving diazepam were significantly more agitated (P = 0.006). Parental rating on a VAS of the child's discomfort after treatment was significantly higher in the diazepam group (P = 0.006). There was a tendency for children with poor acceptance of the rectal administration to display a more negative acceptance of the dental treatment. In conclusion, the present results, in combination with known pharmacological advantages, indicate that midazolam is preferable in outpatients when sedation is needed and amnesia is desirable.     

Comparison of sublingual lorazepam with intramuscular diazepam as sedatives during oral surgery

Sublingual lorazepam (2 to 3 mg) was compared with intramuscular diazepam (0.25 mg/kg) and placebo for sedation during oral surgery under local anesthesia. Sixty patients were randomly allocated into three groups in this double-blind, parallel study. The results from this trial show that sublingually administered lorazepam provided good sedation and anxiolysis. More side-effects, such as giddiness, dizziness, and ptosis, as well as profound and prolonged psychomotor impairment, were, however, found in the lorazepam group than in those patients who had received intramuscular diazepam (0.25 mg/kg) or placebo.     

Comparison of various physiologic and psychomotor parameters in patients sedated with intravenous lorazepam, diazepam, or midazolam during oral surgery

Intravenously administered lorazepam (0.05 mg/kg), diazepam (0.25 mg/kg), and midazolam (0.1 mg/kg) were compared for sedation during oral surgery under local anesthesia. Sixty patients were randomly allocated into three groups in this double-blind, parallel study. The results from this trial show that all three drugs provide satisfactory sedation. Average mean arterial pressures, however, decreased significantly with midazolam and diazepam. Statistically significantly higher heart rates during the entire procedure were also found for lorazepam when compared with diazepam and midazolam. At the postblock stage, the midazolam group had respiratory rates that were significantly higher than those of the other two drug groups. Patients in the diazepam and midazolam groups took significantly longer to complete the pegboard test at the preblock stage than those in the lorzepam group. At 1, 1.5, and 2 hours after arrival in the recovery room, an inversion of groups took place, with the lorazepam group taking significantly longer for their tests than the other two groups. Significantly more improvement in anxiety levels was found at 10 minutes postdrug for the patients who had received diazepam and this tended to remain so on arrival in the recovery room. When compared with the other two groups, significantly more patients in the lorazepam group reported giddiness/dizziness and significantly more in the diazepam group reported pain on injection.     

Assessment of the effects of 2 sedation regimens on cardiopulmonary parameters in pediatric dental patients: a retrospective study

PURPOSE: The purpose of this study was to evaluate the cardiopulmonary effects of 2 sedation regimens during treatment: (1) oral meperidine and hydroxyzine with nitrous oxide (N2O); and (2) oral diazepam and hydroxyzine, submucosal meperidine, and N2O. Nitrous oxide was tapered to oxygen (O2) only 10 minutes following submucosal meperidine administration. METHODS: Sixty-two children were evaluated who met the following criteria: (1) history of uncooperative behavior; (2) ASA I or II; (3) nothing to eat or drink after midnight the night before the appointment; (4) an initial/recall exam prior to the sedation appointment; and (4) patients who met the American Academy of Pediatric Dentistry guidelines for sedation. Regimens I and II included 32 and 30 patients, respectively. A single clinician treated all patients. A Criticare monitor recorded the following at 5-minute intervals: (1) O2 saturation; (2) respiratory rate; (3) heart rate; (4) systolic and diastolic blood pressures; (5) end tidal carbon dioxide concentration; and (6) mean arterial blood pressure. RESULTS: The t test indicated significant differences between the 2 regimens for: (1) heart rate; (2) systolic blood pressure; and (3) diastolic blood pressure (regimen II had higher values). Using the general linear model, no significant differences were found. All cardiopulmonary parameters were within normal limits. CONCLUSION: Regimens I and II had similar cardiopulmonary effects.     

Oral midazolam with and without meperidine for management of the difficult young pediatric dental patient: a retrospective study

PURPOSE: The purpose of this retrospective study was to examine different dosages of midazolam used alone or in combination with different dosages of meperidine for managing difficult young pediatric dental patients. METHODS: Patient records and sedation logs of 120 moderately to severely apprehensive/ uncooperative subjects, ages 24-48 mos, sedated in private practice setting, were reviewed. Subjects, divided into six groups of 20, received midazolam in doses of 0.7 or 1.0 mg/kg with and without meperidine in doses of 1.0 or 1.5 mg/kg. Ratings of the effectiveness of sedation, duration of action, need for restraint to accomplish treatment, and recovery times were made. Nitrous oxide was not used. RESULTS: When used alone, use of 0.7 mg/kg midazolam produced the most agitation, required restraint most frequently, and produced the shortest working time (P<0.001). Subjects receiving 1.0 mg/kg midazolam and meperidine were the most effective, completing 20/20 visits with no need for restraint, no loss of consciousness throughout appointments, and no adverse reactions (P<0.001). Use of lower dose midazolam and higher dose meperidine was reliable, permitting treatment to be completed without restraint in 18/20 patients. Combined higher doses of both agents demonstrated somnolence and oversedation. The addition of meperidine increased working time (P<0.05). CONCLUSIONS: The addition of meperidine appears to enhance the effectiveness and duration of action of midazolam for managing difficult young pediatric patients.