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SUBLINGUAL USE OF ATROPINE IN CONTROLLING DROOLING IN CHILDREN WITH CEREBRAL PALSY: A DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL

SUBLINGUAL USE OF ATROPINE IN CONTROLLING DROOLING IN CHILDREN WITH CEREBRAL PALSY: A DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241022002
Enrollment
116
Registered
2024-10-22
Start date
2024-09-21
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Sublingual Use of Atropine in Controlling Drooling in children with Cerebral Palsy sublingual atropine , cerebral palsay , drooling

Interventions

Intervention: Baseline assessment: Before initiating the treatment, baseline measurements of drooling will be done by applying Drooling Impact Scale (DIS) for all patents meeting the inclusion criteri
Experimental Drug,Placebo Comparator Drug
SUBLINGUAL ATROPINE ADMINISTRATION,SUBLINGUAL NORMAL SALINE

Sponsors

THE CHILDERN HOSPITAL LAHORE
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1) Age 4 -15 years 2) All patient with Cerebral palsy with excessive Drooling According to Operational definition 3) Previously not used any medication or any therapy for drooling 4) Weight more than 10 kg 5)Electrocardiogram normal

Exclusion criteria

Exclusion criteria: 1)Patients with contraindications to atropine. 2)Individuals currently using medications that could interfere with atropine's effects will be excluded to ensure consistent results.

Design outcomes

Primary

MeasureTime frame
efficacy of sublingual atropine in reducing drooling in children with cerebral palsy. BASE LINE ASSESMENT AND AFTER 7 DAYS AT THE END OF INTERVENTION DROOLING IMPACT SCALE (QUALITATIVE)

Secondary

MeasureTime frame
Quality of life , at the end of 7 days of intervention DROOLING IMPACT SCALE ,Safety and tolerability BASE LINE AND AT THE END OF 7 DAYS OF INTERVENTION MONITORING OF SDIE EFECT ,Effects on feeding and swallowing BASE LINE AND 7 DAYS AFTER INTERVENTION DROOLING IMPACT SCALE

Countries

Pakistan

Contacts

Public ContactMUAAZ NAEEM

FELLOW DEVELOPMENTAL AND BEHAVIORAL PEDIATRICS CHILDERN HOSPITAL LAHORE

DRMUAAZNAEEM@GMAIL.COM00923454211421

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026