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A clinical trial to study the effect of two drugs, granisetron and combination of granisetron-dexamethasone on postoperative nausea and vomiting in children undergoing strabismus surgey

Is addition of dexamethasone increases the efficacy of granisetron for prevention of postoperative nausea and vomiting in pediatric strabismus surgery?

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/001000
Enrollment
120
Registered
2009-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- children undergoing strabismus surgery

Interventions

Intervention1: drug - granisetron: 40mcg/kg, once daily Intervention2: granisetron-dexamethasone: granisetron (40mcg/kg)-Dexamethasone (150mcg/kg) once Control Intervention1: granisetron: 40mcg/kg, on

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged 1-14 years undergoing elective strabismus surgery

Exclusion criteria

Exclusion criteria: i. Refusal to participate by parents ii. Difficult airway iii. Mental retardation iv. Severe cardiac/ respiratory disease v. taking drugs which have antiemetic action (phenothiazines, corticosteroids, tricyclic antidepressant) vi. previous history of motion sickness

Design outcomes

Primary

MeasureTime frame
incidence and severity of Post operative nausea and vomiting in first 24 hours after surgeryTimepoint: 24 hours after surgery;incidence and severity of Post operative nausea and vomiting in first 24 hours after surgeryTimepoint: 24 hours after surgery

Secondary

MeasureTime frame
ready to shift to ward from recovery room, parents satisfactionTimepoint: 24 hours postoperatively;ready to shift to ward from recovery room, parents satisfactionTimepoint: 24 hours postoperatively

Countries

India

Contacts

Public ContactDr Renu Sinha
renuagarwal4@rediffmail.com011-26252858

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 2, 2026