Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

NCT02495220 — Phase 2 / Phase 3, Unknown, 80 participants, Assiut University

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

Registry	NCT02495220
Status	Unknown
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	80 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Postoperative Pain, Postoperative Vomiting
Interventions	SB dexmedetomidine bupivacaine block, intravenous dexmedetomidine (Drug)
Dates	start 2015-07-01, primary completion 2017-11-01 (estimated), completion 2017-11-01 (estimated), first posted 2015-07-13, last updated 2017-01-27
Locations	1 site in Egypt

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
subtenon block Group (SB)	Experimental	Drug: SB dexmedetomidine bupivacaine block	received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture
intravenous dexmedetomidine Group(IV)	Experimental	Drug: intravenous dexmedetomidine	received 1µ/kg IV dexmedetomidine after induction of anesthesia

SB dexmedetomidine bupivacaine block (Drug): SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture
intravenous dexmedetomidine (Drug): received 1µ/kg IV dexmedetomidine

+Outcome measures

Primary outcomes

Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics [4 hours postoperatively]: by analysis for number of infants withCRIES pain scale score >3
postoperative CRIES pain scale score [4 hours postoperatively]: (0-2 for each parameter)

Secondary outcomes

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

+Eligibility

Sex: All, ages: 1 Month to 12 Months

Inclusion Criteria:

1. ASA physical status grade I and II infants (1-12month).
2. undergoing elective cataract surgery in one eye under general anesthesia.

Exclusion Criteria:

1. infection of the orbit,
2. increased intraocular pressure(IOP),
3. history of allergy to local anesthetics,
4. history of previous eye surgery,
5. cardiovascular or clotting disorders,
6. full stomach,inner ear disorders or other conditions predisposing to vomiting
7. airway abnormalities
8. compromised sclera.

+Locations (1)

Facility	City	Country	Status
Assiut Univeristy Hospital	Asyut	Egypt	Recruiting