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Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02495220
Enrollment
80
Registered
2015-07-13
Start date
2015-07-31
Completion date
2017-11-30
Last updated
2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Postoperative Vomiting

Keywords

dexmedetomidine, subtenon anesthesia, postoperative pain, pov

Brief 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.

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.

Interventions

DRUGSB dexmedetomidine bupivacaine block

SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture

received 1µ/kg IV dexmedetomidine

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics4 hours postoperativelyby analysis for number of infants withCRIES pain scale score \>3
postoperative CRIES pain scale score4 hours postoperatively(0-2 for each parameter)

Secondary

MeasureTime frameDescription
vomiting scale score4 hours postoperativea 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 periodby analysis

Countries

Egypt

Contacts

Primary Contactjehan A sayed, MD
jehan.alloul@yahoo.com+2 01006253939

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026