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Better Pain and Sedation Checks to Prevent Medicine Withdrawal Problems in Hospitalized Children

IMPACT OF IMPLEMENTATION OF SEDATION AND PAIN ASSESSMENT TOOL TO MITIGATE IATROGENIC WITHDRAWAL SYNDROME IN PEDIATRIC HDU: A QUALITY IMPROVEMENT PROJECT - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105585
Enrollment
180
Registered
2026-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: T808- Other complications following infusion, transfusion and therapeutic injection

Interventions

Intervention1: Application of sedation and pain assessment tool and withdrawal assessment tools: 1.8 hourly FLACC, COMFORT B scale s administration for optimization of sedation and pain in pediatric

Sponsors

Department of Pediatrics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All infants (1 month) and children aged (18years) admitted in the HDU requiring administration of sedative and analgesia agents for management of sedation and analgesia.

Exclusion criteria

Exclusion criteria: Neonates and children with significant neurological impairment and require neuromuscular blocking agents will be excluded. Children shifted to PICU shall be excluded from the study.

Design outcomes

Primary

MeasureTime frame
To implement standardized sedation (COMFORT B scale) and pain (FLACC scale) assessment tools to evaluate their impact on the adequacy of sedation and analgesia, and to reduce both the incidence (to less than 20%) and severity of iatrogenic withdrawal syndrome (IWS) as assessed by the Withdrawal Assessment Tool 1 (WAT 1) among children receiving sedation for more than three days in the Pediatric High Dependency Unit (HDU)Timepoint: 6 months—

Secondary

MeasureTime frame
To improve documentation of sedation and pain scores in pediatric HDU patients within 6 months of implementation. To assess the incidence and severity of iatrogenic withdrawal syndrome before and after implementation of standardized assessment tools. To enhance early identification of children at risk of IWS using validated withdrawal scoring systems (WAT 1). To train healthcare providers in the use of sedation (COMFORT-B), pain (FLACC), and withdrawal (WAT-1) assessment tools. To reduce the duration of unrecognized withdrawal symptoms by improving monitoring and timely intervention. To evaluate the acceptability and feasibility of routine sedation and withdrawal assessment in a pediatric HDU setting. Timepoint: 6 months—

Countries

India

Contacts

Public ContactMANJU NIMESH

Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital

manjulhmc@gmail.com9891220132

Outcome results

None listed

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