Health Condition 1: H262- Complicated cataract Health Condition 2: H263- Drug-induced cataract Health Condition 3: H260- Infantile and juvenile cataract Health Condition 4: H261- Traumatic cataract
Conditions
Interventions
Intervention1: pre-medication with dexmedetomidine: dexmedetomidine
intra-nasal
dose- 2mcs/kg
45 mins before surgery
Intervention2: pre-medication with melatonin: melaotonin
orally
dose-0.5mg/kg
45 m
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: ASA 1 and 2 , between age group 3-9 years
Exclusion criteria
Exclusion criteria: 1.A known allergy or hypersensitive reaction to dexmedetomidine or melatonin 2.Organ dysfunction (renal and hepatic failure, leukemia) 3.Cardiac arrhythmia or congenital disease (congenital cardiac diseases, Pierreâ??Robin syndrome, Downâ??s syndrome) 4.Developmental delay 5.Neurological disease 6.Any active respiratory issues (rhinitis, pneumonia, bronchitis, RSV) 7.Children at risk for airway obstruction (obstructive sleep apnea or a cranio- facial syndrome)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of intranasal dexmedetomidine delivered via mucosal atomizer and oral melatonin in decreasing the incidence of emergence delirium due to sevoflurane in children age group 3-9years undergoing cataract surgeries.Timepoint: post operative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the effect of drugs on preprocedural sedation (By MOASS SCALE) 2.To assess the parental separation before procedure (By parent separation anxiety score) 3.To assess face mask acceptance (By face mask acceptance score) 4.To assess post-operative pain (By FLACC SCORE) 5.To assess parent/guardian satisfaction 6.To assess post op sedation score ( MODIFIED RAMSAY SEDATION SCORE) Timepoint: pre-op, intra-op, post- op | — |
Countries
India
Contacts
Public ContactSameer Sethi
PGIMER, CHANDIGARH
Outcome results
None listed