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

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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A Single Dose of Propofol at the End of Surgery for the Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery during Sevoflurane Anesthesia

Anesthesiology ◽

10.1097/01.anes.0000287009.46896.a7 ◽

2007 ◽

Vol 107 (5) ◽

pp. 733-738 ◽

Cited By ~ 122

Author(s):

Marie T. Aouad ◽

Vanda G. Yazbeck-Karam ◽

Viviane G. Nasr ◽

Mohamad F. El-Khatib ◽

Ghassan E. Kanazi ◽

...

Keyword(s):

Single Dose ◽

Pediatric Anesthesia ◽

Saline Group ◽

Strabismus Surgery ◽

Postanesthesia Care Unit ◽

Double Blind Study ◽

Healthy Children ◽

Emergence Agitation ◽

Double Blind ◽

Emergence Delirium

Background Emergence agitation in children after sevoflurane is common. Different drugs have been used to decrease its occurrence with variable efficacy. The authors compared the incidence and severity of emergence agitation in children who received a single dose of propofol at the end of strabismus surgery versus children who received saline. Methods In this prospective, randomized, double-blind study, the authors enrolled 80 healthy children aged 2-6 yr. The children were randomly allocated to the propofol group (n = 41), which received 1 mg/kg propofol at the end of surgery, or to the saline group (n = 39), which received saline. Results The mean scores on the Pediatric Anesthesia Emergence Delirium scale were significantly lower in the propofol group compared with the saline group (8.6 +/- 3.9 vs. 11.5 +/- 4.5; P = 0.004). Also, the incidence of agitation was significantly lower in the propofol group compared with the saline group (19.5% vs. 47.2%; P = 0.01). A threshold score greater than 10 on the Pediatric Anesthesia Emergence Delirium scale was the best discriminator between presence and absence of emergence agitation. Times to removal of the laryngeal mask airway (10.6 +/- 1.5 vs. 9.4 +/- 1.9 min; P = 0.004) and emergence times (23.4 +/- 5.7 vs. 19.7 +/- 5 min; P = 0.004) were significantly longer in the propofol group. However, discharge times were similar between the two groups (propofol: 34.1 +/- 8.4 min; saline: 34.9 +/- 8.6 min). More parents in the propofol group were satisfied. Conclusions In children undergoing strabismus surgery, 1 mg/kg propofol at the end of surgery after discontinuation of sevoflurane decreases the incidence of agitation and improves parents' satisfaction without delaying discharge from the postanesthesia care unit.

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Effects of ketamine and ketamine with midazolam on emergence agitation in children following sevoflurane anesthesia

Journal of Society of Anesthesiologists of Nepal ◽

10.3126/jsan.v4i2.21205 ◽

2018 ◽

Vol 4 (2) ◽

pp. 57-65

Author(s):

Achyut Sharma ◽

Resham Bahadur Rana

Keyword(s):

Controlled Trial ◽

Pediatric Anesthesia ◽

Sevoflurane Anesthesia ◽

Emergence Agitation ◽

Ophthalmic Surgery ◽

Prospective Randomized Controlled Trial ◽

Recovery Times ◽

The Mean ◽

The Cost ◽

Mean Time

Background : Emergence agitation is a distressful phenomenon associated with inhalational agents such as Sevoflurane in short surgical procedures. Various drugs have been used in the past but some come at the cost of increased complications. We aim to study the effects of ketamine alone and ketamine with midazolam on emergence agitation and their effects on recovery and discharge times.Methods: We conducted a prospective randomized controlled trial among 94 patients aged two to ten years presenting for ophthalmic surgeries in which 45 patients were allocated to each group: group K (Ketamine) and group KM (Ketamine with Midazolam). Group K received Ketamine 0.3 mg/kg IV and Group KM received Ketamine 0.3 mg/kg IV and Midazolam 0.03 mg/kg IV. Intraoperatively heart rate and post-operatively emergence agitation, recovery times, discharge times were studied.Results: Demographic variables were comparable between the two groups. Median Pediatric Anesthesia Emergence Delirium (PAED) score of 6 with IQR (4-6) in group K was comparable to the median score of 5 with IQR (4-6) in group KM. The mean recovery time of 22}4.82 min in group K was significantly lower compared to the mean time of 25.75}3.32 min in group KM. Mean time to discharge of 67}11 min from the hospital in group K was significantly shorter compared to that in group KM (108}18 mins).Conclusion: We concluded from our study that ketamine alone is as effective as ketamine with midazolam in reducing the emergence agitation following Sevoflurane anesthesia for ophthalmic surgery. Journal of Society of Anesthesiologists of NepalVol. 4, No. 2, 2017, page: 57-65

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A Single Dose of Propofol at the End of Surgery for the Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery during Sevoflurane Anesthesia

Yearbook of Anesthesiology and Pain Management ◽

10.1016/s1073-5437(08)70849-0 ◽

2008 ◽

Vol 2008 ◽

pp. 88

Author(s):

S. Black

Keyword(s):

Single Dose ◽

Strabismus Surgery ◽

Sevoflurane Anesthesia ◽

Emergence Agitation

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Frühgeborene unter maschineller Beatmung: Immunmodulatorischer Effekt der präventiven Gabe von Azithromycin

Karger Kompass Pneumologie ◽

10.1159/000513487 ◽

2020 ◽

pp. 1-3

Author(s):

Maximilian Jorczyk

Keyword(s):

Very Low Birth Weight ◽

Controlled Trial ◽

Preterm Neonates ◽

Double Blind ◽

Mechanically Ventilated ◽

Before And After ◽

Anti Inflammatory ◽

To Receive ◽

Therapeutic Possibilities ◽

Inflammatory Effect

Introduction: Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. Objective: The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. Methods: This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for Ureaplasma. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). Results: Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O2 dependency at 28 days/death in azithromycin-treated patients regardless of the detection of Ureaplasma in blood. Conclusions: Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O2 dependency at 28 days/death in mechanically ventilated preterm neonates.

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Methotrimeprazine versus haloperidol in palliative care patients with cancer-related nausea: a randomised, double-blind controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-029942 ◽

2019 ◽

Vol 9 (9) ◽

pp. e029942 ◽

Cited By ~ 2

Author(s):

Janet Rea Hardy ◽

Helen Skerman ◽

Jennifer Philip ◽

Phillip Good ◽

David C Currow ◽

...

Keyword(s):

Palliative Care ◽

Outcome Measures ◽

Controlled Trial ◽

Response Rates ◽

Complete Response ◽

Response To Treatment ◽

Secondary Outcome ◽

Double Blind ◽

Intention To Treat ◽

Point Reduction

ObjectivesMethotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.DesignDouble-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.Setting11 palliative care sites in Australia.ParticipantsParticipants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.InterventionsBased on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.Main outcome measuresA ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.ResultsResponse to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In theper protocolanalysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Completeper protocolresponse rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.ConclusionThis study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.Trial registration numberACTRN 12615000177550.

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Efficacy of Chinese Herbal Medicine Jiangniaosuan Formula for Treatment of Hyperuricemia: Study Protocol For A Double-Blinded Non-Inferiority Randomized Controlled Clinical Trial

10.21203/rs.3.rs-707319/v1 ◽

2021 ◽

Author(s):

Yafang Guo ◽

Hong Lu ◽

Jing Gan ◽

Dongdong Li ◽

Jiandong Gao ◽

...

Keyword(s):

Herbal Medicine ◽

Chinese Herbal Medicine ◽

Serum Uric Acid Level ◽

Controlled Trial ◽

Secondary Outcome ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Chinese Herbal ◽

To Receive ◽

Be The Change

Abstract Background: Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.Methods: A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine i.e., febuxostat 40 mg (WG group; n = 24) or Chinese herbal medicine group, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24)still will receive febuxostat 20 mg + Jiangniaosuan formula and the other group(JNSG; n = 24) will continue to receive Jiangniaosuan formula+Placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in Traditional Chinese Medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.Discussion: We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.Dissemination: The results will be published in a peer-reviewed journal and disseminated by academic conferences.Trial registration : This trial is registered with ClinicalTrials.gov, number ChiCTR2000041083. 22 Registered on 3 May 2021.

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Efficacy of Oral Acetaminophen and Intravenous Chlorpheniramine Maleate versus Placebo to Prevent Red Cell Transfusion Reactions in Children and Adolescent with Thalassemia: A Prospective, Randomized, Double-Blind Controlled Trial

Anemia ◽

10.1155/2018/9492303 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8 ◽

Cited By ~ 2

Author(s):

Piya Rujkijyanont ◽

Chalinee Monsereenusorn ◽

Pimpat Manoonphol ◽

Chanchai Traivaree

Keyword(s):

Blood Transfusion ◽

Controlled Trial ◽

Febrile Reaction ◽

Chlorpheniramine Maleate ◽

Clinical Trial Registry ◽

Double Blind ◽

Urticarial Rash ◽

To Receive ◽

Transfusion Reactions ◽

Rbc Transfusion

Background. Thalassemia is a common congenital hemolytic disorder. In severe cases, regular blood transfusion is essentially required. The role of premedications to prevent transfusion reactions is varied among institutions with no standard guideline. Objective. To prospectively compare the risk of transfusion reactions in thalassemia patients premedicated with acetaminophen and chlorpheniramine maleate (CPM) versus placebo prior to blood transfusion. Material and Method. A randomized, double-blinded, placebo-controlled transfusion reaction study of 147 eligible patients was analyzed. All administered red blood cell (RBC) products were leukoreduced blood products. Patients were monitored and followed for the development of transfusion reactions for 24 hours after RBC transfusion. Results. A total of 73 patients randomized to receive active drugs consisting of acetaminophen and CPM were compared to 74 patients receiving placebo. The overall incidences of febrile reaction and urticarial rash were 6.9% and 22% in the patients randomized to receive active drugs comparing with 9.5% and 35.2% in the patients receiving placebo with no significant differences between two groups. However, delayed development of urticarial rash at 4-24 hours after RBC transfusion was significantly higher in female and patients receiving placebo. Conclusion. Administration of premedications in thalassemia patients receiving RBC transfusion without a history of transfusion reactions does not decrease the overall risk of transfusion reactions. However, the use of CPM might be beneficial to prevent delayed urticarial rash in those patients especially in females (Thai Clinical Trial Registry (TCTR) study ID: 20140526001).

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Effect of oral sugar solution for reducing pain in infants underwent diphtheria, pertussis, tetanus (DPT) im- munization: a randomized, double-blind controlled trial

Paediatrica Indonesiana ◽

10.14238/pi48.1.2008.23-7 ◽

2008 ◽

Vol 48 (1) ◽

pp. 23 ◽

Cited By ~ 2

Author(s):

Arief Priambodo ◽

Madarina Julia ◽

Djauhar Ismail

Keyword(s):

Median Duration ◽

Controlled Trial ◽

Intervention Group ◽

Oral Solution ◽

Health Centers ◽

Sugar Solution ◽

Negative Effects ◽

Double Blind ◽

Primary Health ◽

To Receive

Background Infants are often subjected to painful procedures suchas diphtheria, pertussis, tetanus (DTP) immunization. Despiteits negative effects, pain in infants has not got enough attention.Sweet oral solution has analgesic effect.Objective To determine whether oral sugar solution can reducethe duration of crying in infants who got DTP immunization.Methods This was a randomized, double-blind controlled trialperformed at Growth and Development Clinic of Dr. SardjitoGeneral Hospital and two Primary Health Centers in Yogyakarta.Study subjects were 4-6 month-old infants who got the 3 rd DTPimmunization. Subjects were randomly allocated to receive 2 ml75% oral sugar solution (intervention group) or 2 ml drinkingwater (placebo) just before the immunization. Crying was recordedfrom just before the injection until 3 minutes after.Results Eighty-six subjects were enrolled; 42 subjects receivedsugar solution and 44 subjects received placebo. Sugar solutionreduced the median duration of first cry about 38 seconds or 32%(P=0.03) and reduced the median duration of total crying about35 seconds or 24% (P=0.02).Conclusion Administration of 2 ml 75% oral sugar solution canalleviate pain associated with DTP immunization as shown byreduced duration of crying.

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A double-blind placebo-controlled trial of perioperative prophylactic antibiotics for elective neurosurgery

Journal of Neurosurgery ◽

10.3171/jns.1988.69.5.0687 ◽

1988 ◽

Vol 69 (5) ◽

pp. 687-691 ◽

Cited By ~ 73

Author(s):

Ross Bullock ◽

James R. van Dellen ◽

William Ketelbey ◽

S. Gustav Reinach

Keyword(s):

Controlled Trial ◽

Prophylactic Antibiotics ◽

Risk Of Infection ◽

Broad Spectrum Antibiotic ◽

Wound Sepsis ◽

Double Blind ◽

Content Type ◽

Exact Test ◽

Significant Difference ◽

To Receive

✓ In this study, 417 patients undergoing “clean” elective neurosurgical operative procedures were randomized to receive a broad-spectrum antibiotic (piperacillin) or placebo given as three perioperative doses, each 6 hours apart. Randomization was carried out by hospital pharmacists, and the investigators remained blinded until the end of the study. Twenty cases were excluded from analysis because either an unforeseen second operation was performed or antibiotic therapy was initiated within 30 days after surgery to treat infection or the risk of infection. Twelve of the 205 patients treated with placebo developed postoperative wound sepsis, and four of the 192 piperacillin-treated patients developed wound sepsis — a statistically significant difference (p < 0.05, Fisher's exact test). Piperacillin thus appeared to reduce the incidence of neurosurgical wound infection in this study.

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Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

10.1101/2021.04.13.21255409 ◽

2021 ◽

Author(s):

Juan Manuel Figueroa ◽

Monica Lombardo ◽

Ariel Dogliotti ◽

Luis Flynn ◽

Robert P. Giugliano ◽

...

Keyword(s):

Placebo Group ◽

Nasal Spray ◽

Controlled Trial ◽

Hospital Personnel ◽

Culture Methods ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Efficacy ◽

To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

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