Evaluation of the sedative effect of intranasal versus intramuscular ketamine in 2-6-year-old uncooperative dental patients.

BACKGROUND: Conscious sedation has gained more popularity these days, with different routes of drug administration having various advantages and disadvantages. Among all, ketamine is one of the most commonly used drugs in children. OBJECTIVES: The aim of the present study was to compare 2 different routes of ketamine administration - intranasal (IN) vs. intramuscular (IM) - in 2-6-year-old uncooperative children needing dental treatment. MATERIAL AND METHODS: This single-blind, crossover clinical trial was conducted on a group of 26 uncooperative children aged 2-6 years, who required at least 2 similar dental treatment visits. The patients were randomly assigned into 2 groups: group I - IN ketamine at their 1st session and IM ketamine at the 2nd session; and group II - exactly the opposite sequence. The sedative efficacy of the 2 techniques was assessed by 2 independent pediatric dentists based on the Houpt sedation rating scale. The data was analyzed using the Wilcoxon test, the repeated measures analysis of variance (ANOVA) and the least significant difference (LSD) test. RESULTS: The participants showed reduced crying and movement with improved sleepiness at the 3 time points examined when IM administration was performed as compared to IN sedation (p < 0.05). The overall behavior scores were higher for the IM route as compared to the IN route at all tested time points (p < 0.05). The operating dentist and the parents believed that the IM route was significantly more effective (p < 0.05). The children in the IN session reached equilibrium faster than those in the IM session (p < 0.05). No significant statistical differences were noted between the groups with regard to various physiological parameters investigated at different time intervals. CONCLUSIONS: Intramuscular ketamine was more satisfactory and effective than the IN route when sedating uncooperative children for dentistry.

Comparison of nitrous oxide/midazolam and nitrous oxide/promethazine for pediatric dental sedation: A randomized, cross-over, clinical trial.

BACKGROUND: This study compared the safety and efficacy of nitrous oxide (N2O)/midazolam and N2O/promethazine for dental treatment of uncooperative children. MATERIALS AND METHODS: In this randomized, cross-over, clinical trial investigation Eighteen healthy uncooperative children with a pair of similar teeth requiring the same treatment were included. Combination of N2O/midazolam was given in one visit, where N2O/promethazine was administrated in the other appointment for each patient in a cross-over manner. Oxygen saturation and heart rate as well as behavior parameters according to Houpt behavior scales were recorded. Postoperatively, patients' anxiety and parents' satisfaction were assessed by visual analog score and a questionnaire, respectively. Data were analyzed using Wilcoxon' s signed rank test and Paired t-tests with a P value set at 0.05. RESULTS: Physiologic parameters were within normal limit in both groups. Children in midazolam group were significantly deeper sedated compared to other groups. In the first phase, children sedated with midazolam behaved superiorly in comparison to promethazine, while there was no difference at the final phase of the treatment between the two groups. CONCLUSION: Both of the drug combinations resulted in acceptable, efficient, and safe sedation outcomes.

Comparison of sedative effects of oral midazolam/chloral hydrate and midazolam/promethazine in pediatric dentistry.

Background. The aim of this investigation was to compare the sedative effects of oral midazolam/chloral hydrate and midazolam/promethazine combinations on fearful children needing dental treatment. Methods. This crossover double-blind clinical trial was conducted on 30 children aged 2‒6 years, who had at least two similar teeth needing pulp treatment. Standard vital signs were recorded before and after premedication. Wilson sedation scale was used to judge the level of sedation. Cases were divided into two groups based on the sequence of medication received. This was to overcome the sequence effect. Group I received oral midazolam (0.4 mg/kg/chloral hydrate (50 mg/kg) at the first visit while they received midazolam (0.4 mg/kg)/promethazine (5 mg/kg) in their second visit. Group II received the premedication in the opposite sequence. The operator and child were blinded to the medication administered. Sedative efficacy of the two combinations were assessed and judged by two independent pediatric dentists based on the Wilson scale. Data were analyzed with ANOVA and paired t-test. Results. Only 10% of children who received chloral hydrate with midazolam exhibited high improvement in their behavior while 53% showed reasonable positive changes and 12% had no change or even deterioration of behavior. The difference between the effect of the two combination drugs was statistically significant (P<0.05) in favor of the chloral hydrate group. Conclusion. The results showed a significant difference in the sedation level induced between the two groups. Midazolam/chloral hydrate combination more effectively improved the co-operation for dental treatment.

Conscious Sedation Efficacy of 0.3 and 0.5 mg/kg Oral Midazolam for Three to Six Year-Old Uncooperative Children Undergoing Dental Treatment: A Clinical Trial.

OBJECTIVES: Midazolam with variable dosages has been used to induce sedation in pediatric dentistry. The aim of this study was to compare the efficacy of two dosages of oral midazolam for conscious sedation of children undergoing dental treatment. MATERIALS AND METHODS: In this randomized crossover double blind clinical trial, 20 healthy children (ASA I) aged three to six years with definitely negative Frankl behavioral rating scale were evaluated. Half of the children received 0.5mg/kg oral midazolam plus 1mg/kg hydroxyzine (A) orally in the first session and 0.3mg/kg oral midazolam plus 1mg/kg hydroxyzine (B) in the next session. The other half received the drugs on a reverse order. Sedation degree by Houpt sedation rating scale, heart rate and level of SpO2 were assessed at the beginning and after 15 and 30 minutes. The data were analyzed using SPSS 19 and Wilcoxon Signed Rank and McNemar's tests. RESULTS: The results showed that although administration of 0.5mg/kg oral midazolam was slightly superior to 0.3mg/kg oral midazolam in terms of sedation efficacy, the differences were not significant (P>0.05). The difference in treatment success was not significant either (P>0.05). Heart rate, oxygen saturation (SpO2) and respiratory rate were within the normal range and did not show a significant change (P>0.05). CONCLUSIONS: The overall success rate of the two drug combinations namely 0.5mg/kg oral midazolam plus hydroxyzine and 0.3mg/kg oral midazolam plus hydroxyzine was not significantly different for management of pediatric patients.

Comparison of Oral and Intranasal Midazolam/Ketamine Sedation in 3-6-year-old Uncooperative Dental Patients.

Background and aims. There are several known sedative drugs, with midazolam and ketamine being the most commonly used drugs in children. The aim of this study was to compare the effect of intranasal and oral midazolam plus ketamine in children with high levels of dental anxiety. Materials and methods. A crossover double-blind clinical trial was conducted on 23 uncooperative children aged 3-6 (negative or definitely negative by Frankel scale), who required at least two similar dental treatment visits. Cases were randomly given ketamine (10 mg/kg) and midazolam (0.5 mg/kg) through oral or intranasal routes in each visit. The sedative efficacy of the agents was assessed by an overall success rate judged by two independent pediatric dentists based on Houpt's scale for sedation. Data analysis was carried out using Wilcoxon test and paired t-test. Results. Intranasal administration was more effective in reduction of crying and movement during dental procedures compared to oral sedation (P<0.05). Overall behavior control was scored higher in nasal compared to oral routes at the time of LA injection and after 15 minutes (P<0.05). The difference was found to be statistically significant at the start and during treatment. However, the difference was no longer significant after 30 minutes, with the vital signs remaining within physiological limits. Recovery time was longer in the intranasal group (P<0.001) with a more sleepy face (P=0.004). Conclusion. . Intranasal midazolam/ketamine combination was more satisfactory and effective than the oral route when sedating uncooperative children.

Sedative Effect of Oral Midazolam/Hydroxyzine versus Chloral Hydrate/Hydroxyzine on 2-6 Year-Old Uncooperative Dental Patients: A Randomized Clinical Trial.

OBJECTIVE: Different drugs are used for conscious sedation in pediatric dentistry either single or in combination. This study assessed the comparative effect of midazolam/hydroxyzine and chloral hydrate/hydroxyzine on 2-6 year-old uncooperative children needing dental treatment. MATERIALS AND METHODS: A double blind cross-over randomized clinical trial was designed and 16 children aged 2-6 years with ASA1 status who were judged with negative to definitely negative behavior (according to Frankl) were chosen. Cases were divided randomly into two groups. The first group received midazolam/hydroxyzine (MH) at the first visit while the second group received chloral hydrate/hydroxyzine (CHH) as the first medication. Both groups received the other regimen at the second visit. Midazolam 0.5mg/kg and chloral hydrate 50mg/kg with 1mg/kg hydroxyzine were administered. Cases were subsequently assessed for sedation and then dental treatment was performed. Blood oxygen saturation (SpO2) and pulse rate (PR) were measured before and after drug administration, as well as during and after dental treatment. The Houpt scale was also used for the level of sedation before, during and after treatment. Data were analyzed using Wilcox-on signed rank test and the paired t-test. RESULTS: Sedative success rate was 64.3% in cases of MH and 33.3% in CHH. The difference between groups was significant (P=0.046). The success rate was significantly different between groups at different measurement stages as well (P<0.05). No difference was found on the child's behavior scale based on the type of drugs used first; this indicates no carry-over effect. Comparing the PR and SpO2 values at different readings showed no significant differences. CONCLUSION: Midazolam/hydroxyzine showed a significantly higher sedative effect than chloral hydrate/hydroxyzine in this study.

Comparison of oral Midazolam-Ketamine and Midazolam-Promethazine as sedative agents in pediatric dentistry.

BACKGROUND: Investigation was designed to evaluate the behavioral changes in children receiving dental treatment while they have been administered combination of Midazolam/Ketamine or Midazolam/Promethazine. MATERIALS AND METHODS: This was a randomized double blind clinical trial with cases being selected from those uncooperative children aged 2 to 6 years from those referred for treatment under general anesthesia. Anxiety score of all cases were recorded before any attempt using Frankel's anxiety scoring system with those in negative category being included. Cases with at least a pair of similar size cavities on similar teeth were selected with each tooth being randomly allocated for one sedative regimen group. To avoid sequence effect, half of the patients received one regimen at the first visit while the other half received the other regimen as the first. Each case served as control for him or herself to reduce influencing factors. Child's reaction was recorded before, during, and at the end of dental procedure. SO2 as well as Pulse rate were recorded as the most critical vital signs. Collected data were then analyzed using analysis of variance (ANOVA) and paired t-test. RESULTS: Patients' mean age was 3.5 years with 43% being male. Only 10% of the Ketamine/Midazolam group showed considerable amount of change in their behavior with a statistical significant difference being presented (P=0.029). CONCLUSION: Under the current circumstances, Ketamine/Midazolam combination provided sufficient sedative effect in lower doses. However, Midazolam/Promethazine combination did not produce similar results.

Efficacy of bupivacaine-neostigmine and bupivacaine-tramadol in caudal block in pediatric inguinal herniorrhaphy.

BACKGROUND: Limited duration of analgesia is among the limitations of single caudal injection with local anesthetics. Therefore, the purpose of this study was to evaluate the effectiveness and safety of bupivacaine in combination with either neostigmine or tramadol for caudal block in children undergoing inguinal herniorrhaphy. METHODS: In a double-blinded randomized trial, sixty children undergoing inguinal herniorrhaphy were enrolled to receive a caudal block with either 0.25% bupivacaine (1 ml x kg(-1)) with neostigmine (2 microg x kg(-1)) (group BN) or tramadol (1 mg x kg(-1)) (group BT). Hemodynamic variables, pain and sedation scores, additional analgesic requirements, and side effects were compared between two groups. RESULTS: Duration of analgesia was longer in group BT (17.30 +/- 8.24 h) compared with group BN (13.98 +/- 10.03 h) (P = 0.03). Total consumption of rescue analgesic was significantly lower in group BT compared with group BN (P = 0.04). There were no significant differences in heart rate, mean arterial pressure, and oxygen saturation between groups. Adverse effects excluding the vomiting were not observed in any patients. CONCLUSION: In conclusion, tramadol (1 mg x kg(-1)) compared with neostigmine (2 microg x kg(-1)) might provide both prolonged duration of analgesia and extended time to first analgesic in caudal block.

Gil-Vernet antireflux surgery in children's primary vesicoureteral reflux.

PURPOSE: The assessment of the results of Gil-Vernet antireflux surgery in children with primary vesicoureteral reflux. MATERIALS AND METHODS: In a descriptive retrospective study, 72 patients with vesicoureteral reflux (VUR) and 104 refluxing units underwent Gil-Vernet antireflux surgery in Mofid children's hospital from Dec 2000 to Nov 2005. The study group was selected from among the patients with VUR who had been operated in our center. Data were collected from the medical records of the patients in the archive of the hospital and analyzed for gender, age, method of diagnosis, side of involvement, grading types, usage of catheter and stent, operating time, hospital stay, reflux down grading, operative success rate, recurrence and operative complication. RESULTS: Among 72 patients, 47 (65%) were females and 25 (35%) were males with a mean age of 4.35 ± 2.96 years (range 1-13 years). 32 patients had bilateral and 40 had unilateral reflux, and 76% were in grades III and IV. Mean operative time was 55 ± 13 min, median hospital stay was 2 ± 0.9 days and mean follow-up period was 48 ± 9 months. Reflux was improved completely in 100 (96.15%) refluxing units, and down-graded in 4 (3.84%) units. Treatment was performed medically in 2 and surgically in 2 refluxing units, and all were improved successfully. There were no complications post-operatively. CONCLUSION: Gil-Vernet antireflux technique is a useful method, and it has many advantages such as simplicity, shorter operative time, lower complication rate and high success rate.

Diphallus with imperforate anus and complete duplication of recto-sigmoid colon and lower urinary tract.

BACKGROUND: Diphallus is a rare anomaly and accompanying anomalies vary from bifid scrotum, bladder exstrophy, imperforate anus and colo-rectal anomaly such as duplication, and other associated anomalies. CASE PRESENTATION: A 2-day old infant is reported with imperforate anus and complete duplication of recto-sigmoid colon, rectal pouch, doubling of the genitalia with completely formed penis (diphallus), double bladder, urethra and hypospadias. No family history of abnormalities was noted. The patient underwent several operations: laparatory and colostomy at 3rd day of life, and after clinical and paraclinical investigations, cystoplasty, ureteral reimplantation and resection of left phallus were carried out when 4 months old. At the age of 1 year, after colostogram and total colon evaluation, laparatomy, resection of duplicated recto-sigmoid colon, and pull-through was carried out; 3 months later colostomy closure was performed and the patient discharged without complications. CONCLUSION: The patients with diphallus have to be examined carefully because of the high incidence of other systemic anomalies. Treatment of diphallus usually includes excision of the duplicated penile structure, its urethra, and repair of associated anomalies.