Dataset Information

Hydroxyzine Dihydrochloride Premedication Is a Necessity for Pediatric Patients Undergoing Strabismus Surgery: An Observational Prospective Clinical Trial.

ABSTRACT:

Objective

In this single-blind, observational prospective clinical trial, we aimed to determine and compare the effects of premedication with hydroxyzine plus midazolam and midazolam alone on the incidence of oculocardiac reflex (OCR).

Methods

Forty-five patients were divided into three groups. Group M received 0.5 mg/kg midazolam alone, Group H received 0.5 mg/kg hydroxyzine plus 0.5 mg/kg midazolam, and Group HM received 1 mg/kg hydroxyzine plus 0.5 mg/kg midazolam. The Ramsay Sedation Scale (RSS), the heart rates (HR1: after induction of anesthesia; HR2: before retraction of orbital muscle; and HR3: right after retraction of orbital muscle), the muscles with OCR, and the incidence of OCR (20% decrease of the HR right after the traction) were recorded and compared between the three groups.

Results

The mean HR1, HR2, and HR3 values were significantly increased (p=0.002, p < 0.001, p < 0.001) and the incidence of OCR (p=0.004) was significantly decreased in Group H and in Group HM (for all, p < 0.01) compared to Group M. The most common orbital muscle in which OCR occurred was the rectus medialis.

Conclusion

Premedication with a combination of 0.5 or 1 mg hydroxyzine with 0.5 mg midazolam significantly reduced the incidence of OCR compared to premedication with midazolam alone. This study was registered on https://clinicaltrials.gov/ with number NCT03806270.

SUBMITTER: Kartufan FF

PROVIDER: S-EPMC9519320 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Hydroxyzine Dihydrochloride Premedication Is a Necessity for Pediatric Patients Undergoing Strabismus Surgery: An Observational Prospective Clinical Trial.

Kartufan Fatma Ferda FF Kizilcik Nurcan N Ziylan Sule S Menda Ferdi F

Journal of ophthalmology 20220921

<h4>Objective</h4>In this single-blind, observational prospective clinical trial, we aimed to determine and compare the effects of premedication with hydroxyzine plus midazolam and midazolam alone on the incidence of oculocardiac reflex (OCR).<h4>Methods</h4>Forty-five patients were divided into three groups. Group M received 0.5 mg/kg midazolam alone, Group H received 0.5 mg/kg hydroxyzine plus 0.5 mg/kg midazolam, and Group HM received 1 mg/kg hydroxyzine plus 0.5 mg/kg midazolam. The Ramsay S ...[more]

PMID: 36189149

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Project description:BackgroundPreoperative fear and anxiety are prevalent in children undergoing surgery. The combination of esketamine and dexmedetomidine has been proposed as a promising premedication for enhancing preoperative sedation and analgesia. This study compared the premedication efficacy of intranasal esketamine alone and esketamine-dexmedetomidine combination in pediatric patients undergoing strabismus surgery.MethodsOne hundred and eighty preschool children aged 2-6 years scheduled for strabismus surgery were enrolled and randomly assigned to one of the three groups: intranasal premedication with esketamine 2 mg/kg (Group K), esketamine 1 mg/kg and dexmedetomidine 1 µg/kg (Group KD1), or esketamine 0.5 mg/kg and dexmedetomidine 2 µg/kg (Group KD2). The primary outcome was the level of sedation following the intervention, as measured by the modified Yale preoperative anxiety scale (mYPAS) and sedation scale (SS). Secondary outcomes included onset time of sedation, the successful rate of peripheral intravenous cannulation, parental separation anxiety scale (PSAS), mask acceptance scale (MAS), wake-up time, duration of stay in the post-anesthesia care unit (PACU), and premedication-related adverse effects.ResultsAfter premedication, the mYPAS score gradually decreased in the three groups, with lower values in Group K than in Group KD1 and Group KD2 patients in 1, 5, and 10 min. SS in Group KD1 and Group KD2 steadily increased until 40 min after premedication, while SS in Group K increased in the first 5 min after premedication and maintained consistent levels during the remaining time. Sedation onset was substantially faster in Group K patients (11.4±7.8 min) than Group KD1 (18.1±7.5 min, P=0.006) and Group KD2 (18.4±6.8 min, P<0.001). PSAS, separation status, the successful rate of peripheral intravenous cannulation, and MAS were comparable among groups. There was no significant difference in terms of emergence time or duration of stay in the PACU among groups. More gastrointestinal events were observed in Group K (P<0.001).ConclusionsIntranasal premedication with 2 mg/kg esketamine produced a more rapid onset of sedation accompanied by more gastrointestinal reactions compared with a combination of esketamine and dexmedetomidine.Trial registrationClinicalTrials.gov identifier: NCT04757675.

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Project description:PurposeTo determine the cumulative incidence of strabismus surgery after pediatric cataract surgery and identify the associated risk factors.DesignUS population-based insurance claims retrospective cohort study.ParticipantsPatients ≤ 18 years old who underwent cataract surgery in 2 large databases: Optum Clinformatics Data Mart (2003-2021) and IBM MarketScan (2007-2016).MethodsIndividuals with at least 6 months of prior enrollment were included, and those with a history of strabismus surgery were excluded. The primary outcome was strabismus surgery within 5 years of cataract surgery. The risk factors investigated included age, sex, persistent fetal vasculature (PFV), intraocular lens (IOL) placement, nystagmus and strabismus diagnoses before cataract surgery, and cataract surgery laterality.Main outcome measuresKaplan-Meier estimated cumulative incidence of strabismus surgery 5 years after cataract surgery and hazard ratios (HRs) with 95% confidence intervals (CIs) from multivariable Cox proportional hazards regression models.ResultsStrabismus surgery was performed on 271/5822 children included in this study. The cumulative incidence of strabismus surgery within 5 years after cataract surgery was 9.6% (95% CI, 8.3%-10.9%). Children who underwent strabismus surgery were more likely to be of younger age at the time of cataract surgery, of female sex, have a history of PFV or nystagmus, have a pre-existing strabismus diagnosis, and less likely to have an IOL placed (all P < 0.001). Factors associated with strabismus surgery in the multivariable analysis included age 1 to 4 years (HR, 0.50; 95% CI, 0.36-0.69; P < 0.001) and age > 5 years (HR, 0.13; 95% CI, 0.09-0.18; P < 0.001) compared with age < 1 year at time of cataract surgery, male sex (HR, 0.75; 95% CI, 0.59-0.95; P < 0.001), IOL placement (HR, 0.71; 95% CI, 0.54-0.94; P = 0.016), and strabismus diagnosis before cataract surgery (HR, 4.13; 95% CI, 3.17-5.38; P < 0.001). Among patients with strabismus diagnosis before cataract surgery, younger age at cataract surgery was the only factor associated with increased risk of strabismus surgery.ConclusionsApproximately 10% of patients will undergo strabismus surgery within 5 years after pediatric cataract surgery. Children of younger age, female sex, and with a pre-existing strabismus diagnosis undergoing cataract surgery without IOL placement are at greater risk.Financial disclosuresThe author(s) have no proprietary or commercial interest in any materials discussed in this article.

Dataset Information

Hydroxyzine Dihydrochloride Premedication Is a Necessity for Pediatric Patients Undergoing Strabismus Surgery: An Observational Prospective Clinical Trial.

Objective

Methods

Results

Conclusion

Publications

Hydroxyzine Dihydrochloride Premedication Is a Necessity for Pediatric Patients Undergoing Strabismus Surgery: An Observational Prospective Clinical Trial.

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