Efficacy of Sublingual Atropine to Minimize Drooling in Children with Cerebral Palsy: A Double-Blind Randomized Controlled Trial

Hafiz Muhammad Muaaz  Naeem; Hina  Azhar; Muneeba  Malik; Aisha  Farid; Ammara  Hina; Anam  Ali

doi:10.51253/pafmj.v76iSUPPL-1.13459

Authors

Hafiz Muhammad Muaaz Naeem Developmental & Behavioural Pediatrics, University of Child Health Sciences, the Childern Hospital Lahore Pakistan https://orcid.org/0009-0007-2877-5341
Hina Azhar Developmental & Behavioural Pediatrics, University of Child Health Sciences, the Childern Hospital Lahore Pakistan
Muneeba Malik Developmental & Behavioural Pediatrics, University of Child Health Sciences, the Childern Hospital Lahore Pakistan
Aisha Farid Developmental & Behavioural Pediatrics, University of Child Health Sciences, the Childern Hospital Lahore Pakistan
Ammara Hina Developmental & Behavioural Pediatrics, University of Child Health Sciences, the Childern Hospital Lahore Pakistan
Anam Ali Developmental & Behavioural Pediatrics, University of Child Health Sciences, the Childern Hospital Lahore Pakistan

DOI:

https://doi.org/10.51253/pafmj.v76iSUPPL-1.13459

Keywords:

Atropine, Cerebral Palsy, Drooling, Randomized Controlled Trial, Sublingual

Abstract

Objective: To determine the efficacy of sublingual Atropine in reducing drooling episodes compared to placebo, thereby improving the quality of life of patients, and potentially offering a noninvasive treatment modality.

Study Design: Randomized Controlled Trial (Registered with Thai Clinical Trials Registry TCTR20241022002)

Place and Duration of Study: Department of Developmental & Behavioral Pediatrics, The Children’s Hospital & University of Child Health Sciences, Lahore, Pakistan, from Sep 2024 to Mar 2025.

Methodology: A total of 116 participants enrolled, with 58 participants in each group. Two patients withdrew due to significant side effects in the intervention group. During a predetermined period, participants were randomized to receive either sublingual Atropine (intervention group-A, n = 56) or a placebo (Group-B, n = 58). The primary outcome was the composite score of the Drooling Impact Scale (DIS).

Results: Baseline Drooling Impact Scale (DIS) scores were comparable between intervention and placebo groups, with median (IQR) of 77.0(70.0–82.0) and 74.5(65.0–83.5), respectively (p = 0.686). Baseline median Drooling Impact Scale (DIS) score decreased from 77.0(IQR 70.0–82.0) to 54.5(IQR 36.8–78.0) to post-intervention (p<0.001). The median reduction in total DIS scores from baseline was −22.5 (−35.2 to −12.0) in the intervention group compared with −2.5 (−10.0 to +5.0) in the placebo group (p<0.001), indicating a significant reduction in drooling severity.

Conclusion: Sublingual Atropine is a safe, effective, and non-invasive treatment for drooling in children with cerebral palsy, offering significant clinical and quality-of-life improvements.

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Author Biography

Muneeba Malik, Developmental & Behavioural Pediatrics, University of Child Health Sciences, the Childern Hospital Lahore Pakistan

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