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comparison of two sedation technique in children with congenital heart disease.

Comparison of two different techniques of sedation in children with complex cardiac disease undergoing CT angiography; Prospective Randomised Study - Nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059539
Enrollment
60
Registered
2023-11-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: B- Imaging

Interventions

Intervention1: PARENTS LAP WITH KETAMINE: a combination of midazolam 0.05 mg/kg, glycopyrrolate 0.01 mg/kg and ketamine 0.5 mg/kg iv with the child in the parents lap inside the CT suite. Ketamine wil

Sponsors

Post Graduate Institute of Medical Education ResearchChandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: child with diagnosed complex cyanotic congenital heart disease (ASA III or IV) with baseline saturation less than 90 per cent requiring sedation for cardiac CT angiography.

Exclusion criteria

Exclusion criteria: 1. Acyanotic CHD 2. Older children >3 years 3. refusal of consent by parents 4. Active URI 5. Contraindication for contrast (CKD) 6. Contrast allergy 7. Full stomach children

Design outcomes

Primary

MeasureTime frame
To quantify the difference in dose of ketamine required to achieve a Pediatric Sedation State Scale of 2 between the two techniques (lap vs table).Timepoint: From the onset of the sedation process till the achievement of PSSS 2. up to 30 minutes.

Secondary

MeasureTime frame
1. To record any episodes of desaturation and bradycardia (reversal of shunt). 2. To record the total amount of ketamine required during the whole procedure. 3. To compare the time to achieve the Paediatric Sedation State Scale of 2 4. Time required to awaken the child, the Watcha scale will be noted every 10 minutes in the recovery room till a Steward scale of 7 has been achieved.Timepoint: From 30 minutes before the sedation till discharge

Countries

India

Contacts

Public ContactAJAY SINGH

Post Graduate Institute of Medical Education & Research, Chandigarh

ajay.ydv2509@gmail.com09999276845

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026