Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

Study Overview
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Brief Summary
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The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.

Detailed Description
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In this prospective, randomized, controlled, double blind trial eighty ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia were studied. Infants were randomly allocated to one of the two groups: subtenon block Group (SB) with dexmedetomidine (n =40) or intravenous dexmedetomidine Group (IV) (n =40). After securing the airway, infants in Group (SB) received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture, whereas infants in Group (IV) received 1µ/kg IV dexmedetomidine after induction of anesthesia. Surgery started after 5 min of study drug administration. Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics was the primary outcome. CRIES pain scale score , vomiting scale score during4-h study period, incidence of oculocardiac reflex and any surgical difficulty were the Secondary outcomes.

Official Title
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Subtenon Versus Intravenous Dexmedetomidine for Postoperative Analgesia and Vomiting Control in Infantile Cataract Surgery

Conditions
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Postoperative Pain, Postoperative Vomiting

Intervention / Treatment
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* Drug: SB dexmedetomidine bupivacaine block
* Drug: intravenous dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status grade I and II infants (1-12month). undergoing elective cataract surgery in one eye under general anesthesia. Exclusion Criteria: infection of the orbit, increased intraocular pressure(IOP), history of allergy to local anesthetics, history of previous eye surgery, cardiovascular or clotting disorders, full stomach,inner ear disorders or other conditions predisposing to vomiting airway abnormalities compromised sclera.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subtenon block Group (SB)<br>received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture | Drug: SB dexmedetomidine bupivacaine block<br>* SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture<br>|
| Experimental: intravenous dexmedetomidine Group(IV)<br>received 1µ/kg IV dexmedetomidine after induction of anesthesia | Drug: intravenous dexmedetomidine<br>* received 1µ/kg IV dexmedetomidine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics | by analysis for number of infants withCRIES pain scale score >3 | 4 hours postoperatively | 
| postoperative CRIES pain scale score | (0-2 for each parameter) | 4 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vomiting scale score | a numeric rank score, where 0= no vomiting 1=vomited once and 2=vomited twice or more | 4 hours postoperative | 
| Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%). | by analysis | intraoperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pov, dexmedetomidine, subtenon anesthesia, postoperative pain