A comparison study between ketamine and ketamine-promethazine combination for oral sedation in pediatric dental patients

This study compared the incidence of vomiting and the sedative effectiveness of ketamine to a ketamine-prornethazine combination in pediatric dental patients. Twenty-two patients with American Society of Anesthesiologists' classification I physical status who were between the ages of 21 and 43 months were randomly divided into 2 groups. The control group received 10 mg/kg of ketamine orally, whereas the experimental group received 10 mg/kg of ketamine and 1.1 mg/kg of promethazine orally. Nitrous oxide in oxygen was supplemented between 35 and 50%. Each patient received 1 or 2 quadrants of restoration by one operator. Heart rate, blood pressure, and oxygen saturation were monitored and recorded during the treatment. Crying, alertness, movement, and overall general behavior were rated using the scale by Houpt et al. A dentist-anesthesiologist conducted the vital sign monitoring and behavioral assessment. Ketamine combined with promethazine eliminated the incidence of vomiting. A 2 x 2 chi-square contingency table showed a statistical difference between the 2 groups at P < .05 (control group, 27%; experimental group, 0%). Ketamine alone yielded better sedations than the combined agents as shown by the Mann-Whitney U statistical analysis (P < .05). Ketamine and a ketamine-promethazine combination are effective in the sedation of pediatric dental patients.     

A pilot study of the efficacy of oral midazolam for sedation in pediatric dental patients.

Oral midazolam is being used for conscious sedation in dentistry with little documentation assessing its efficacy. In order to accumulate preliminary data, a randomized, double-blind, controlled, crossover, multi-site pilot study was conducted. The objective was to determine if 0.6 mg/kg of oral midazolam was an equally effective or superior means of achieving conscious sedation in the uncooperative pediatric dental patient, compared with a commonly used agent, 50 mg/kg of oral chloral hydrate. Twenty-three children in three clinics who required dentistry with local anesthetic and were determined to exhibit behavior rated as "negative" or "definitely negative" based on the Frankl scale were assessed. They were evaluated with respect to acceptance of medication; initial level of anxiety at each appointment; level of sedation prior to and acceptance of local anesthetic; movement and crying during the procedure; and overall behavior. The results showed that the group randomly assigned to receive midazolam had a significantly greater initial level of anxiety for that appointment (P < 0.02), a finding that could clearly confound further determination of the efficacy of these drugs. Patients given oral midazolam had an increased level of sedation prior to the administration of local anesthetic compared with those given chloral hydrate (P < 0.015). No statistically significant differences were noted in any of the other parameters. The age of the patient was found to have no correlation with the difference in overall behavior (r = -0.09). These preliminary data warrant further clinical trials.     

A comparison of four sedation techniques for pediatric dental surgery

Background: We prospectively assessed the efficacy and side effects of four sedation techniques in our dental clinic: oral midazolam, intranasal (IN) midazolam, IN midazolam combined with oral transmucosal fentanyl citrate (OTFC), and IN midazolam combined with IN sufentanil. Materials & Methods: With IRB approval, a nonrandomized open label study of moderate sedation in children undergoing dental surgery was administered during a 6 ‐month period. The sedation regimen was rotated daily at the anesthesiologist’s discretion. Each sedation was monitored by a research nurse who assessed the quality of sedation and the frequency of complications. All children were monitored during the procedure and recovery for at least 20 min, before discharge based on the University of Michigan Sedation and Ohio State behavior rating scores. Results: One hundred and two children were sedated in the dental clinic during this period. The sedation was successful in 73% (range 64% to 88%) of the children. The time to onset was greatest with OTFC (37 min) and least with IN midazolam (17 min) compared with the other two groups (20 and 30 min). Recovery after OTFC was prolonged (39 min) significantly compared with the other three groups (26.5–30 min). Efficacy of sedation and frequency of complications (9% incidence of nausea and 6% of mild hemoglobin desaturation) were similar among the groups. Conclusions: All four sedation regimens were equally effective in this cohort of healthy children. The onset and recovery with OTFC was significantly delayed compared with the other regimens. The frequency of side effects was small; there were no side effects in the PO midazolam group.     

A combination of oral diazepam and droperidol for premedication. A double blind comparison with diazepam alone

Oral diazepam is commonly used as a premedicant. For a given dose there is considerable between patient variation in clinical effect and plasma levels. The addition of droperidol may improve consistency and contribute antiemesis whilst avoiding the undesirable effects of droperidol alone. Ninety patients undergoing minor gynecological or minor urological surgery were given as an oral premedicant either diazepam (0.185 mg/kg) or one of two combinations of diazepam and droperidol (diazepam, 0.185 mg/kg plus droperidol, 0.09 mg/kg; or diazepam, 0.135 mg/kg plus droperidol, 0.09 mg/kg). There was no significant difference between the groups in altering mean anxiety measurements or improving consistency of action as judged by the number of patients having reduced anxiety measurements. Side effects, including nausea and vomiting, were not significantly different between the three groups. In the doses used there was no practical advantage in adding droperidol to diazepam for oral premedication.     

A comparison of oral midazolam and nitrous oxide sedation for dental extractions in children

The aim of the study was to compare oral midazolam and inhaled nitrous oxide as sedative agents during the management of children aged 5-10 years presenting for extraction of primary teeth under local anaesthetic. Subjects required two visits for the extraction of four primary teeth, one in each quadrant of the mouth, and were randomly allocated to be given nitrous oxide 30% in oxygen or oral midazolam 0.3 mg.kg(-1) at the first visit, the other technique being used at the second visit. Vital signs, sedation levels and behavioural scores were recorded, and postoperative recall and satisfaction were reported by the patients. Thirty-five children, with a mean [range] age of 7.4 [5-10] years, completed the treatment. The mean dose of oral midazolam given was 8.6 [3.3-16.5] mg. The mean times taken to achieve the maximum level of sedation for midazolam and nitrous oxide sedation were 15.9 [2-30] min and 6.8 [2-10] min, respectively. Physiological parameters remained within acceptable clinical limits for both types of sedation. Oral midazolam was considered acceptable by 59% and was preferred by 36%. Oral midazolam sedation in 5 to 10-year-old children was shown to be as safe and effective as nitrous oxide in oxygen sedation for extraction of primary teeth but would not be the method of choice for all patients.     

Flumazenil reversal of midazolam sedation for dental procedures.

The efficacy of flumazenil in the reversal of midazolam sedation was assessed in double-blind placebo controlled study. Thirty patients undergoing oral surgical procedures were included. Flumazenil administration was followed by immediate rise of the CNS functions scores to almost the baseline awake values. Compared to control group, patients were significantly more oriented and had better comprehension up to 15 minutes, more alert for 30 minutes and had better memory function up to 60 minutes. Peripheral oxygen saturation was significantly higher up to 15 minutes. Flumazenil allows better utilization and higher turn over rate where space and nursing resources are scarce.     

Remifentanil versus morphine analgesia and sedation for mechanically ventilated critically ill patients: a randomized double blind study

BACKGROUND: The rapid onset and offset of action of remifentanil could make it quickly adjustable to the required level of sedation in critically ill patients. The authors hypothesized that the efficacy of a remifentanil-based regimen was greater than that of a morphine-based regimen. METHODS: Forty intent-to-treat patients were randomly allocated to receive a blinded infusion of either remifentanil 0.15 microg x kg(-1) x min(-1) or morphine 0.75 microg x kg(-1) x min(-1). The opioid infusion was titrated, in the first intent, to achieve optimal sedation defined as Sedation Agitation scale of 4. A midazolam open-label infusion was started if additional sedation was required. RESULTS: The mean percentage hours of optimal sedation was significantly longer in the remifentanil group (78.3 +/- 6.2) than in the morphine group (66.5 +/- 8.5). This was achieved with less frequent infusion rate adjustments (0.34 +/- 0.25 changes/h) than in the morphine group (0.42 +/- 0.22 changes/h). The mean duration of mechanical ventilation and extubation time were significantly longer in the morphine group (18.1 +/- 3.4 h, 73 +/- 7 min) than in the remifentanil group (14.1 +/- 2.8 h, 17 +/- 6 min), respectively. Remifentanil mean infusion rate was 0.13 +/- 0.03 microg x kg(-1) x min(-1), whereas morphine mean infusion rate was 0.68 +/- 0.28 microg x kg(-1) x min(-1). More subjects in the morphine group (9 of 20) than in the remifentanil group (6 of 20) required midazolam. The incidence of adverse events was low and comparable across the two treatment groups. CONCLUSIONS: A remifentanil-based regimen was more effective in the provision of optimal analgesia-sedation than a standard morphine-based regimen. The remifentanil-based regimen allowed a more rapid emergence from sedation and facilitated earlier extubation.     

A comparison of the effects of propofol and nitrous oxide on the electroencephalogram in epileptic patients during conscious sedation for dental procedures.

The influence of sedative doses of propofol or nitrous oxide on the electroencephalogram was studied in 11 mentally handicapped patients with treated epilepsy undergoing dental procedures. At one session, propofol was titrated to achieve conscious sedation. The mean (+/- SD) dose requirements were 5.5 +/- 1.1 mg.kg-1.h-1. In six patients, the electroencephalogram was unchanged during propofol administration. In three patients, there was a decrease in epileptic activity, and in two patients, paroxysmal discharges disappeared. At another session, nitrous oxide was administered by nasal mask. The mean (+/- SD) concentration of nitrous oxide needed was 43.6% +/- 4.8%. The electroencephalogram did not change in nine patients, whereas in two patients epileptic activity decreased. There were no clinical epileptoid or other adverse manifestations during any treatment or up to 48 h thereafter. The results of the present study suggest that propofol or nitrous oxide can be administered in subanesthetic doses for conscious sedation in mentally handicapped patients with treated epilepsy.     

A cost analysis of treating pediatric dental patients using general anesthesia versus conscious sedation.

The purpose of this pilot study is to report a cost comparison of general anesthesia (GA) versus oral conscious sedation (CS) for pediatric dental patients. The study sample included 22 children whose parents or guardians selected GA care for their child. Selection criteria limited inclusion to healthy children (American Society of Anesthesiologists' classification I) aged 24-60 months. The subjects acted as their own comparison group to an estimation CS model. Models were developed to assess societal costs for treatment under GA and CS. Treatment rendered was equalized using the dental relative based value unit scale.     

Bispectral index monitoring of sedation depth in pediatric dental patients

The bispectral index (BIS) monitor records electroencephalogram waveforms and provides an objective measure of the hypnotic effect of a sedative drug on brain activity. The aim of this pilot study was to use the BIS monitor to evaluate the depth of procedural sedation in pediatric dental patients and to assess if the BIS monitor readings correlate with a validated pediatric sedation scale, the University of Michigan Sedation Scale (UMSS), in determining the level of sedation in these patients. Thirty-five pediatric dental patients requiring sedation were studied prospectively. A baseline BIS reading was obtained and during the procedure an independent observer recorded the BIS every 5 minutes. The operator, who was blinded to the BIS results, determined the UMSS scale at the same 5-minute interval. The patients were monitored postoperatively for 1 hour. There was a significant but moderate correlation between BIS values and UMSS scores (Spearman's rank correlation r = -0.574, P < .0001). Percentage of agreement and kappa coefficient using all the observations were also calculated. The percentage of agreement was 37.8%, the kappa coefficient was 0.18 (P < .0001), and the weighted kappa coefficient 0.26 (P < .0001). A lack of correlation was noted between the deeper levels of UMSS sedation scores and BIS values. This study demonstrated a significant correlation between BIS values and the UMSS score in pediatric dental patients undergoing mild to moderate sedation. Based on our results, it appears that the BIS monitor may be useful during mild or moderate sedations to establish the level of sedation objectively without the need to stimulate the patient.     

A double blind comparison of alfentanil and fentanyl

Alfentanil and fentanyl were compared as supplements to thiopentone, nitrous oxide, relaxant anaesthesia in a randomised, double blind trial carried out on 55 adult patients undergoing elective surgery. The fentanyl-treated patients resumed spontaneous ventilation more rapidly at the end of anaesthesia (3 minutes) than the alfentanil-treated group (5.1 minutes, p less than 0.02). In other respects the drugs appeared indistinguishable. A computer model is used to explain why, despite the shorter elimination half-life, the alfentanil-treated patients did not awaken more rapidly than those in the fentanyl group.     

Efficacy of oral midazolam for minimal and moderate sedation in pediatric patients: A systematic review

One of the most widely used options for minimal/moderate sedation in pediatric patients is oral midazolam, as it presents an alternative to less well‐accepted routes of administration (eg, intravenous or intranasal) of this well‐known efficacious and well‐tolerated short‐acting benzodiazepine. A systematic review of the literature was conducted in order to identify clinical studies evaluating the effectiveness of oral midazolam for sedation in pediatric patients in the context of premedication before anesthesia or during diagnostic/treatment procedures. The percentage of responders (response rate) after single administration of oral midazolam was evaluated and compared versus placebo in a subset of placebo‐controlled studies. The range of oral midazolam doses providing effective sedation in the different pediatric age subsets was analyzed in order to assess optimum dosing strategies. A total of 25 pediatric clinical studies, utilizing a variety of measures of sedation effectiveness, were selected. These studies included a total of 1472 patients (aged 4 months‐18 years) treated with midazolam (0.25‐1.5 mg/kg) and 138 patients treated with placebo. The response rates [95% confidence interval] with oral midazolam ranged from 36.7% [21.6%, 54.9%] to 97.8% [86.1%, 99.7%], while with placebo response rates ranged from 4.0% [0.6%, 23.5%] to 41.0% [29.4%, 53.6%]. When considering the 4 placebo‐controlled studies, the odds ratios [95% confidence interval] for the comparison of midazolam vs. placebo ranged from 13.4 [5.0, 36.0] to 25.9 [6.7, 100.6]. The analysis of subgroups by context of sedation showed response rates [95% confidence interval] with oral midazolam ranging from 36.7% [21.6%, 54.9%] to 97.0% [94.8%, 98.3%] for anesthetic premedication and from 56.1% [43.1%, 68.4] to 97.8% [86.1%, 99.7%] for medical procedures. The efficacy of midazolam for pediatric minimal/moderate sedation from a dose of 0.25 mg/kg and above was demonstrated. The probability of occurrence of adverse events and over‐sedation increases with increasing doses.     

A comparison of dexmedetomidine sedation with and without midazolam for dental implant surgery

Dexmedetomidine (DEX) has a minimal respiratory depressive effect, which is beneficial for dentistry; however, it has the disadvantage of permitting an intraoperative arousal response such that the patient appears to be suddenly no longer sedated, and it has a variable amnestic effect. Since midazolam (MDZ) in an appropriate dose has a profound amnesic effect, we investigated whether additional MDZ compensates for the disadvantage of DEX and enables a better quality of sedation. Forty-three subjects were randomly divided into 4 groups. In group 1, MDZ (0.02 mg/kg) was administered intravenously, followed by a dose of 0.01 mg/kg every 45 minutes. After the first dose of MDZ, preloading with DEX (2 µg/kg/h for 10 minutes) was started and maintained with a dosage of 0.5 µg/kg/h. In group 2, MDZ was infused in the same manner as in group 1, followed by preloading with DEX (1 µg/kg/h for 10 minutes) and maintenance (0.3 µg/kg/h). In group 3, MDZ was infused 0.03 mg/kg, and a dose of 0.01 mg/kg was given every 30 minutes; DEX was administered at the same as in group 2. In group 4, DEX was infused using the same method as in group 1 without MDZ. The sedation levels, amnesia, and patient satisfaction were also investigated. Group 2 had a lower sedation level and a poor evaluation during the first half of the operation. Group 4 did not exhibit an amnesic effect at the beginning of the operation. An evaluation of the degree of patient satisfaction did not reveal any differences among the groups. Optimal sedation was achieved through the combined use of MDZ (0.02 mg/kg with the addition of 0.01 mg/kg every 45 minutes) and DEX (2 µg/kg/h for 10 minutes followed by 0.5 µg/kg/h).     

Safety evaluation of fospropofol for sedation during minor surgical procedures

Study ObjectiveTo evaluate the safety of intravenous (IV) fospropofol when used to provide minimal to moderate sedation in patients undergoing minor surgical procedures.DesignPhase 3, open-label, single-arm study.SettingMulti-center.Patients123 ASA physical status I, II, III, and IV patients, aged ≥18 years.InterventionsPatients were pretreated with fentanyl 50 μg before receiving an initial dose of IV fospropofol 6.5 mg/kg. Patients could receive up to 5 supplemental doses of fospropofol 1.63 mg/kg to reach a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 4 to allow the start of the procedure and to maintain adequate sedation levels during the procedure.MeasurementsStudy endpoints included measures of sedation depth, requirement for supplemental sedative doses, use of alternative sedatives, and the frequency and nature of treatment-emergent and sedative-related adverse events.Main ResultsA mean of 2.4 supplemental doses of fospropofol was administered, and in 60% of patients, two or fewer supplemental doses of fospropofol were sufficient to initiate and complete the procedure. Alternative sedative medication was administered in 6 of 123 patients (4.9%). Mean (SD) MOAA/S score during the procedure was 3.8 (0.5). Sixty-one percent (61%) of patients had a MOAA/S score of 5 (fully alert) within two minutes after the end of the procedure. Few patients (7 of 123; 5.7%) had MOAA/S scores of 0 to 1 (deep sedation) during the procedure, and all 7 were either ASA physical status I (n = 1) or II (n = 6). The most common treatment-related adverse events (TRAEs) were self-limited: paresthesias (62.6%) and pruritus (27.6%). Five patients experienced sedation-related adverse events, including hypotension (n = 4), bradycardia (concurrently with hypotension and managed with atropine; n = 1), or hypoxemia (less than one min and managed with chin lift and verbal stimulation; n = 1). Twenty patients with previous or existing hepatic disease (ranging from minimal to severe) and 5 patients with severe renal impairment had adverse events similar to the overall population. No deaths were reported, and no patient discontinued the study due to adverse events.ConclusionAn initial dose of IV fospropofol 6.5 mg/kg with supplemental doses was safe and well-tolerated as moderate sedation for use in minor surgical procedures.