The effect of midazolam administration for the prevention of emergence agitation in pediatric patients with extreme fear and non-cooperation undergoing dental treatment under sevoflurane anesthesia, a double-blind, randomized study

OBJECTIVES: Emergence agitation (EA) is a common and troublesome problem in pediatric patients recovering from general anesthesia. The incidence of EA is reportedly higher after general anesthesia maintained with sevoflurane, a popular inhalational anesthetic agent for pediatric patients. We conducted this prospective, randomized, double-blind study to test the effect of an intravenous ultra-short–acting barbiturate, thiamylal, administered during induction of general anesthesia on the incidence and severity of EA in pediatric patients recovering from Sevoflurane anesthesia. METHODS: Fifty-four pediatric patients (1 to 6 years of age) undergoing subumbilical surgeries were randomized into 2 groups. Patients received either intravenous thiamylal 5mg/kg (Group T) or inhalational Sevoflurane 5% (Group S) as an anesthetic induction agent. Following induction, general anesthesia was maintained with Sevoflurane and nitrous oxide (N2O) in both groups. To control the intra- and post-operative pain, caudal block or ilioinguinal/iliohypogastric block was performed. The incidence and severity of EA were evaluated by using the Modified Objective Pain Scale (MOPS: 0 to 6) at 15 and 30 min after arrival in the post-anesthesia care unit (PACU). RESULTS: Fifteen minutes after arrival in the PACU, the incidence of EA in Group T (28%) was significantly lower than in Group S (64%; p = 0.023) and the MOPS in Group T (median 0, range 0 to 6) was significantly lower than in Group S (median 4, range 0 to 6; p = 0.005). The interval from discontinuation of Sevoflurane to emergence from anesthesia was not significantly different between the 2 groups. CONCLUSIONS: Thiamylal induction reduced the incidence and severity of EA in pediatric patients immediately after Sevoflurane anesthesia.

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Faculty Opinions recommendation of Dexmedetomidine decreases emergence agitation in pediatric patients after sevoflurane anesthesia without surgery.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.30747.487162 ◽

2006 ◽

Author(s):

Victor Baum

Keyword(s):

Pediatric Patients ◽

Sevoflurane Anesthesia ◽

Emergence Agitation

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DEXMEDETOMIDINE REDUCES AGITATION AND PROVIDES SMOOTH EXTUBATION AFTER PAEDIATRIC ADENOTONSILLECTOMY

10.36106/ijsr/6018820 ◽

2020 ◽

pp. 1-5

Author(s):

Mehak Gul ◽

Umar Nisar Shah ◽

Mohd Rafi Denthoo ◽

Basharat Ahad

Keyword(s):

Pain Score ◽

Normal Saline ◽

Pediatric Patients ◽

Tracheal Extubation ◽

Sevoflurane Anesthesia ◽

Emergence Agitation ◽

Rescue Analgesia ◽

Extubation Time ◽

Operative Recovery ◽

Post Operative Nausea

OBJECTIVES : To study the role of dexmedetomidine on emergence agitation and its effect on extubation in paediatric adenotonsillectomy. Our study involves the assessment of postoperative pain by Objective Pain Scale and need for rescue analgesia and other untoward events in PACU. The study also included the comparision of post operative recovery time by Modified Aldrete Recovery Score using dexmedetomidine and normal saline in adenotonsillectomy for pediatric patients. METHODS : After induction of general anesthesia patient was put on controlled ventilation and maintained on sevoflurane 1.5-2% with 66% O2 and 33% N2O. At the end of surgery patients received either dexmedetomidine or normal saline over a period of 5 minutes, sevoﬂurane and nitrous oxide were discontinued, and residual muscle relaxation was reversed. Tracheal extubation time (time from anesthetic gas discontinue to tracheal extubation) and emergence time (time from anesthetic gas discontinue to eye opening on command) were recorded. Incidence of untoward airway events after extubation were also noted. The subject’s postoperative behaviour was assessed using Pediatric Anesthesia Emergence Delirium (PAED). In PACU, the intensity of pain was assessed by using an observational pain score (OPS). Any untoward events were noted and patient was shifted as per modified PACU score. RESULTS: In this randomized comparative study, single dose of dexmedetomidine (0.5mcg/kg) was found to be associated with a statistically significant decrease in the incidence of emergence agitation along with smooth extubation in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia. In addition, lower incidence of post-operative nausea and vomiting, lower pain score and shorter duration of stay in post-anesthesia care unit were observed. Although it was seen that the extubation was prolonged in the dexmedetomidine group in comparison to the placebo. CONCLUSION: Dexmedetomidine reduces emergence agitation and provides smooth extubation in pediatric adenotonsillectomy patients on sevoflurane anesthesia.

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The Effect of Ondansetron on the Emergence Agitation after Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy

Korean Journal of Anesthesiology ◽

10.4097/kjae.2007.53.5.598 ◽

2007 ◽

Vol 53 (5) ◽

pp. 598

Author(s):

Kun Moo Lee ◽

Dong Hwa Kang ◽

Sang Eun Lee ◽

Young Hwan Kim ◽

Se Hun Lim ◽

...

Keyword(s):

Pediatric Patients ◽

Sevoflurane Anesthesia ◽

Emergence Agitation

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Randomized Study of Phentolamine Mesylate for Reversal of Local Anesthesia

Journal of Dental Research ◽

10.1177/154405910808700717 ◽

2008 ◽

Vol 87 (7) ◽

pp. 635-639 ◽

Cited By ~ 21

Author(s):

M. Laviola ◽

S.K. McGavin ◽

G.A. Freer ◽

G. Plancich ◽

S.C. Woodbury ◽

...

Keyword(s):

Soft Tissue ◽

Local Anesthetic ◽

Dental Treatment ◽

Randomized Study ◽

Study Drug ◽

Negative Consequences ◽

Double Blind ◽

Dental Procedures ◽

Phase 2 Study ◽

Pulpal Anesthesia

Local anesthetic solutions frequently contain vasoconstrictors to increase the depth and/or duration of anesthesia. Generally, the duration of soft-tissue anesthesia exceeds that of pulpal anesthesia. Negative consequences of soft-tissue anesthesia include accidental lip and tongue biting as well as difficulty in eating, drinking, speaking, and smiling. A double-blind, randomized, multicenter, Phase 2 study tested the hypothesis that local injection of the vasodilator phentolamine mesylate would shorten the duration of soft-tissue anesthesia following routine dental procedures. Participants (122) received one or two cartridges of local anesthetic/vasoconstrictor prior to dental treatment. Immediately after treatment, 1.8 mL of study drug (containing 0.4 mg phentolamine mesylate or placebo) was injected per cartridge of local anesthetic used. The phentolamine was well-tolerated and reduced the median duration of soft-tissue anesthesia in the lip from 155 to 70 min (p < 0.0001).

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

Journal of Clinical Pediatric Dentistry ◽

10.17796/1053-4628-39.4.382 ◽

2015 ◽

Vol 39 (4) ◽

pp. 382-386 ◽

Cited By ~ 2

Author(s):

D Flores-Castillo ◽

R Martínez-Rider ◽

S Ruiz-Rodríguez ◽

A Garrocho-Rangel ◽

J Lara-Guevara ◽

...

Keyword(s):

Pediatric Patients ◽

Dental Treatment ◽

Body Movement ◽

Blood Oxygen ◽

Random Assignment ◽

Blood Oxygen Saturation ◽

Double Blind ◽

Moderate Sedation ◽

Randomized Controlled ◽

Pharmacological Method

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.

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Dexmedetomidine as bolus or low-dose infusion for the prevention of emergence agitation with sevoflurane anesthesia in pediatric patients

Anesthesia Essays and Researches ◽

10.4103/aer.aer_177_18 ◽

2019 ◽

Vol 13 (1) ◽

pp. 57 ◽

Cited By ~ 1

Author(s):

PremRaj Singh ◽

Uzma Begum ◽

Bhavya Naithani ◽

Vinita Singh ◽

GP Singh ◽

...

Keyword(s):

Low Dose ◽

Pediatric Patients ◽

Sevoflurane Anesthesia ◽

Emergence Agitation ◽

Dose Infusion

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Effectiveness of steroids vs placebo in preventing upper airway obstruction after extubation in critically-ill children: rationale and design of a multicentric, double-blind, randomized study.

10.21203/rs.2.12891/v2 ◽

2019 ◽

Author(s):

Gema Manrique ◽

Laura Butragueño Laiseca ◽

Rafael González ◽

Corsino Rey ◽

Zuriñe Martínez ◽

...

Keyword(s):

Airway Obstruction ◽

Pediatric Patients ◽

Randomized Study ◽

Upper Airway ◽

Upper Airway Obstruction ◽

Critically Ill Children ◽

Controlled Study ◽

Double Blind ◽

To Receive

Abstract Background Post-extubation upper airway obstruction (UAO) is a frequent complication causing stridor and respiratory distress, which occasionally may require reintubation, thereby increasing morbidity and mortality rates. Contradictory results have been obtained in studies assessing the effectiveness of steroids in preventing post-extubation UAO, and the available evidence is limited. We designed a multicentric randomized, placebo-controlled study to explore the effectiveness of dexamethasone in preventing post-extubation UAO in children. Methods A multicentric, prospective, double-blind, randomized, placebo-controlled, phase IV clinical trial has been designed. The sample will include pediatric patients between 1 month and 16 years of age who have been intubated for more than 48 hours. Patients with airway disorders or who have received steroids within the last seven days will be excluded. Patients will be randomized to receive either placebo or a therapy with dexamethasone 0.25 mg/kg every 6 hours to be started 6-to-12 hours prior to extubation, to a total of four doses. Randomization will be performed at a 1:1 ratio. Follow-up of patients will be carried out for 48 h after extubation. The main objective of this study is to assess the reduction of UAO symptoms following extubation, as measured using the Taussig scale. Secondary objectives include assessing the decrease in the incidence of reintubation, evaluating the use of additional therapies for upper airway obstruction, and monitoring dexamethasone potential side effects. Discussion The results of this study will contribute to the existing evidence on prophylaxis for post-extubation airway obstruction.

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Comparison of the Effects of 0.03 and 0.05 mg/kg Midazolam with Placebo on Prevention of Emergence Agitation in Children Having Strabismus Surgery

Anesthesiology ◽

10.1097/aln.0000000000000181 ◽

2014 ◽

Vol 120 (6) ◽

pp. 1354-1361 ◽

Cited By ~ 37

Author(s):

Eun Jung Cho ◽

Seung Zhoo Yoon ◽

Jang Eun Cho ◽

Hye Won Lee

Keyword(s):

Intravenous Administration ◽

Controlled Trial ◽

Pediatric Anesthesia ◽

Strabismus Surgery ◽

Secondary Outcome ◽

Sevoflurane Anesthesia ◽

Emergence Agitation ◽

Emergence Time ◽

Double Blind ◽

To Receive

Abstract Background: Midazolam has been widely studied for preventing emergence agitation. The authors previously reported that in children with sevoflurane anesthesia, intravenous administration of midazolam (0.05 mg/kg) before the end of surgery reduced the incidence of emergence agitation but prolonged the emergence time. This study was designed to test the hypothesis that a lower midazolam dose could suppress emergence agitation with minimal disturbance of the emergence time in children with sevoflurane anesthesia. Methods: In this randomized, double-blind, placebo-controlled trial, 90 children (1 to 13 yr of age) having strabismus surgery were randomized to 1:1:1 to receive 0.03 mg/kg of midazolam, 0.05 mg/kg of midazolam, or saline just before the end of surgery. The primary outcome, the incidence of emergence agitation, was evaluated by using the pediatric anesthesia emergence delirium scale and the four-point agitation scale. The secondary outcome was time to emergence, defined as the time from sevoflurane discontinuation to the time to extubation. Results: The incidence of emergence agitation was lower in patients given 0.03 mg/kg of midazolam (5 of 30, 16.7%) and patients given 0.05 mg/kg of midazolam (5 of 30, 16.7%) compared with that in patients given saline (13/of 30, 43.3%; P = 0.036 each). The emergence time was longer in patients given 0.05 mg/kg of midazolam (17.1 ± 3.4 min, mean ± SD) compared with that in patients given 0.03 mg/kg of midazolam (14.1 ± 3.6 min; P = 0.0009) or saline (12.8 ± 4.1 min; P = 0.0003). Conclusion: Intravenous administration of 0.03 mg/kg of midazolam just before the end of surgery reduces emergence agitation without delaying the emergence time in children having strabismus surgery with sevoflurane anesthesia. (Anesthesiology 2014; 120:1354-61)

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Effectiveness of Steroids vs Placebo in Preventing Upper Airway Obstruction After Extubation in Critically-Ill Children: Rationale and Design of a Multicentric, Double-Blind, Randomized Study

10.21203/rs.2.12891/v4 ◽

2020 ◽

Author(s):

Gema Manrique ◽

Laura Butragueño Laiseca ◽

Rafael González ◽

Corsino Rey ◽

Zuriñe Martínez ◽

...

Keyword(s):

Airway Obstruction ◽

Pediatric Patients ◽

Randomized Study ◽

Upper Airway ◽

Upper Airway Obstruction ◽

Critically Ill Children ◽

Controlled Study ◽

Double Blind ◽

To Receive

Abstract Background: Post-extubation upper airway obstruction (UAO) is a frequent complication causing stridor and respiratory distress, which occasionally may require reintubation, thereby increasing morbidity and mortality rates. Contradictory results have been obtained in studies assessing the effectiveness of steroids in preventing post-extubation UAO, and the available evidence is limited. We designed a multicentric randomized, placebo-controlled study to explore the effectiveness of dexamethasone in preventing post-extubation UAO in children. Methods: A multicentric, prospective, double-blind, randomized, placebo-controlled, phase IV clinical trial has been designed. The sample will include pediatric patients between 1 month and 16 years of age who have been intubated for more than 48 hours. Patients with airway disorders or who have received steroids within the last seven days will be excluded. Patients will be randomized to receive either placebo or a therapy with dexamethasone 0.25 mg/kg every 6 hours to be started 6-to-12 hours prior to extubation, to a total of four doses. Randomization will be performed at a 1:1 ratio. Follow-up of patients will be carried out for 48 h after extubation. The main objective of this study is to access the reduction in the incidence of moderate-severe UAO symptoms following extubation. Secondary objectives include assessing the decrease in the incidence of reintubation, evaluating the use of additional therapies for upper airway obstruction, and monitoring dexamethasone potential side effects. Discussion: The results of this study will contribute to the existing evidence on prophylaxis for post-extubation airway obstruction. Trial registration: EudraCT identifier, 2009-016596-30. Registered on 11 May 2010.

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