Subcutaneous Midazolam with and without Ketamine for Sedation In Children Undergoing Dental Treatment: A Pilot Study

2015 ◽  
Vol 39 (4) ◽  
pp. 382-386 ◽  
Author(s):  
D Flores-Castillo ◽  
R Martínez-Rider ◽  
S Ruiz-Rodríguez ◽  
A Garrocho-Rangel ◽  
J Lara-Guevara ◽  
...  

Aim: The objective of this study was to evaluate the efficacy of subcutaneous (SC) sedation using midazolam with and without ketamine in non-cooperative pediatric patients undergoing dental treatment. Study Design: A prospective, randomized, controlled, double-blind, crossover pilot clinical trial was carried out in 13 children, aged between 17–46 months, ASA l, Frankl 1. Two sedation schemes were administered SC: Midazolam alone (M), and a combination of Midazolam-Ketamine (MK). Both regimens were administered to the same patient in two consecutive treatment sessions, in accordance with a random assignment. Overall behavior, movement, and crying were assessed according to the modified Houpt scale. Heart rate, blood pressure, blood oxygen saturation, and possible side effects were also monitored. Results: The percentage of non-crying children was always higher in the treatment with MK compared with the treatment with M, but without a significant statistical difference. Regarding variable body movement, the percentage of children without movement was higher in the MK group, although only up to minute 10; no significant differences were found at 20, 30, and 40 minutes, and from minute 40, body movement was lower in the M group. Conclusions: Midazolam alone and the midazolam-ketamine combination administered subcutaneously resulted in a safe and efficient pharmacological method for providing moderate sedation to non-cooperative pediatric patients undergoing dental treatment.

2016 ◽  
Vol 34 (19) ◽  
pp. 2287-2293 ◽  
Author(s):  
Lidewij T. Warris ◽  
Marry M. van den Heuvel-Eibrink ◽  
Femke K. Aarsen ◽  
Saskia M.F. Pluijm ◽  
Marc B. Bierings ◽  
...  

Purpose Dexamethasone is a key component in the treatment of pediatric acute lymphoblastic leukemia (ALL), but can induce serious adverse effects. Recent studies have led to the hypothesis that neuropsychological adverse effects may be a result of cortisol depletion of the cerebral mineralocorticoid receptors. We examined whether including a physiologic dose of hydrocortisone in dexamethasone treatment can reduce neuropsychologic and metabolic adverse effects in children with ALL. Patients and Methods We performed a multicenter, double-blind, randomized controlled trial with a crossover design. Of 116 potentially eligible patients (age 3 to 16 years), 50 were enrolled and were treated with two consecutive courses of dexamethasone in accordance with Dutch Childhood Oncology Group ALL protocols. Patients were randomly assigned to receive either hydrocortisone or placebo in a circadian rhythm (10 mg/m2/d) during both dexamethasone courses. Primary outcome measure was parent-reported Strength and Difficulties Questionnaire in Dutch, which assesses psychosocial problems. Other end points included questionnaires, neuropsychological tests, and metabolic parameters. Results Of 48 patients who completed both courses, hydrocortisone had no significant effect on outcome; however, a more detailed analysis revealed that in 16 patients who developed clinically relevant psychosocial adverse effects, addition of hydrocortisone substantially reduced their Strength and Difficulties Questionnaire in Dutch scores in the following domains: total difficulties, emotional symptoms, conduct problems, and impact of difficulties. Moreover, in nine patients who developed clinically relevant, sleep-related difficulties, addition of hydrocortisone reduced total sleeping problems and disorders of initiating and maintaining sleep. In contrast, hydrocortisone had no effect on metabolic parameters. Conclusion Our results suggest that adding a physiologic dose of hydrocortisone to dexamethasone treatment can reduce the occurrence of serious neuropsychological adverse effects and sleep-related difficulties in pediatric patients with ALL.


2015 ◽  
Vol 63 (2) ◽  
pp. 153-160 ◽  
Author(s):  
Alessandra Rodrigues de Almeida LIMA ◽  
Marcelo MEDEIROS ◽  
Luciane Rezende COSTA

OBJECTIVE: Moderate sedation has limits in managing children's behavior. Existing literature lacks insight into parental perceptions about the topic. This study aimed to understand mothers' perceptions concerning sedation after their children undergone dental treatment under sedation. METHODS: Twelve mothers and one godmother of 1.3-8.4 year-old children with definitely negative behavior in the dental chair, who had dental treatment under oral sedation, were in depth interviewed according to a semi-structured guide. Responses were analysed using a thematic content method and deductive approach. Two general themes were addressed: "good facet" and "poor facet" of pediatric dental sedation. RESULTS: Analysis of interview transcripts indicated that participants perceived pediatric dental sedation according to two main analytical categories: the "good facet" and the "poor facet". The good facet included advantages of the procedure (e.g. safety, effective behavior management), rapport and completion of the treatment that was initially planned. The poor facet related to limitations of moderate sedation (when child kept struggling) and their own anxiety during the procedure. CONCLUSION: Despite their own stress, mothers were satisfied with this pharmacological method of behavior management.


2019 ◽  
Vol 34 (5) ◽  
pp. 248-255 ◽  
Author(s):  
Jeremias Antinew ◽  
Bruno Pitrosky ◽  
Lloyd Knapp ◽  
Mary Almas ◽  
Verne Pitman ◽  
...  

Efficacy and safety of pregabalin as adjunctive treatment for children (aged 4-16 years) with partial-onset seizures, hereafter termed focal onset seizures for this study, was evaluated. This double-blind, randomized, placebo-controlled, international study had 3 phases: 8-week baseline, 12-week double-blind treatment (2-week dose escalation; 10-week fixed dose), and 1-week taper. Selection criteria included experiencing focal onset seizures and receiving a stable regimen of 1 to 3 antiepileptic drugs. Study treatments were pregabalin 2.5 mg/kg/d, 10 mg/kg/d, or placebo; doses were increased to 3.5 or 14 mg/kg/d for subjects weighing <30 kg. The key endpoints were change in loge(28-day seizure rate), achieving a ≥50% seizure responder rate, safety, and tolerability during double-blind treatment. Subjects (n = 295; mean age 10.2 years, 55% male, 69% white) were randomized to pregabalin 2.5 mg/kg/d (n = 104), 10 mg/kg/d (n = 97), or placebo (n = 94). A statistically significant reduction in loge(28-day seizure rate) was demonstrated with pregabalin 10 mg/kg/d (a 19.9% improvement over placebo; P = .0185). Seizure frequency was numerically improved (statistically nonsignificant) with pregabalin 2.5 mg/kg/d ( P = .2577). Responder rate significantly favored pregabalin 10 mg/kg/d (40.6%, P = .0068) compared with placebo (22.6%) and was numerically improved with pregabalin 2.5 mg/kg/d (29.1%, P = .2600). Common adverse events (≥10% of any group) in 10 mg/kg/d, 2.5 mg/kg/d, and placebo groups, respectively, included somnolence (25.8%, 17.3%, 13.8%), increased weight (13.4%, 3.8%, 4.3%), and increased appetite (10.3%, 6.7%, 4.3%). Pregabalin 10 mg/kg/d demonstrated efficacy in seizure frequency reduction in children with focal onset seizures compared with placebo, and both pregabalin doses were generally safe and well tolerated. www.clinicialtrials.gov identifier NCT01389596; EudraCT #2010-020852-79


1993 ◽  
Vol 21 (6) ◽  
pp. 825-829 ◽  
Author(s):  
MARK J. HEULITT ◽  
ELIZABETH A. FARRINGTON ◽  
T. MICHAEL OʼSHEA ◽  
SUSAN M. STOLTZMAN ◽  
NANCY B. SRUBAR ◽  
...  

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