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Clinical trial to compare sedation and analgesia rotation and non rotation protocol in mechanically ventilated children

Sedative and analgesic drug rotation protocol vs non rotation protocol in mechanically ventilated children: a randomized controlled trial - SANDRP TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049865
Enrollment
58
Registered
2023-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: Z991- Dependence on respirator

Interventions

Intervention1: Rotation of sedative and analgesia drugs: In intervention group sedative and analgesic drugs will be rotated at specific time durations Patient on mechanical ve

Sponsors

Aiims jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children between one month to 18 years whose anticipated duration of requiring sedation and analgesia is for more than 3 days (72 hours). 2. Parents or guardians giving informed written consent for enrollment of child into study.

Exclusion criteria

Exclusion criteria: Patients in whom drug rotation may not be possible as they would be requiring deeper sedation like in pulmonary hypertension.

Design outcomes

Primary

MeasureTime frame
To compare the occurrence of withdrawal symptoms in sedation drug rotation protocol versus sedation with no rotation using WAT-1 (withdrawal assessment tool version 1). Timepoint: After 1 year (March 2024)

Secondary

MeasureTime frame
1.To compare the cumulative dose of midazolam needed as rescue therapy in both groups. 2.To compare the total duration of mechanical ventilation in each group. 3.To compare the total duration of PICU stay in each group.Timepoint: Till 1 year (March 2024)

Countries

India

Contacts

Public ContactUPPALURI NAGA PRADEEP BABU

AIIMS JODHPUR

daisykhera78@gmail.com8003996913

Outcome results

None listed

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