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Updated: Oct 9, 2025
Author Spotlight: Methodologies and Advancements of Chronic Pain Management Research
Published on: January 5, 2024
Efficacy of amitriptyline in pediatric functional abdominal pain disorders: A randomized placebo-controlled trial
Jayendra Seetharaman1, Ujjal Poddar1, Surender Kumar Yachha1
1Department of Pediatric Gastroenterology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India.
Insights
Amitriptyline significantly improved pain and quality of life in children with functional abdominal pain disorders. This treatment offers sustained relief for many children, supporting its use in clinical settings.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
- Pain Management
Background:
- Functional abdominal pain disorders (FAPD) are common in children, with variable treatment outcomes.
- Amitriptyline has shown efficacy in adults with FAPD, but pediatric data are inconsistent.
Purpose of the Study:
- To evaluate the efficacy and safety of amitriptyline in pediatric patients diagnosed with FAPD.
- To compare treatment outcomes between amitriptyline and placebo groups in children with FAPD.
Main Methods:
- An open-label randomized trial involving 149 children (≤18 years) diagnosed with FAPD.
- Participants received either amitriptyline or placebo for 12 weeks, with outcomes assessed against baseline.
- Key outcome measures included pain reduction and quality of life (QOL) improvements.
Main Results:
- Amitriptyline significantly reduced pain intensity, frequency, and duration, and improved QOL compared to placebo (P < 0.001).
- 76% of children on amitriptyline experienced >50% pain reduction, versus 14.9% in the placebo group (P < 0.001).
- Amitriptyline use was the sole predictor of response (OR 24.1, P < 0.001), with comparable minor adverse events.
Conclusions:
- A 3-month course of amitriptyline provides sustained pain relief in a majority of children with FAPD.
- The drug's favorable safety and efficacy profile supports its increased use in pediatric FAPD management.
- Extended treatment and post-discontinuation follow-up indicate long-term benefits for many patients.
Background And Aim:
Amitriptyline improves symptoms in functional abdominal pain disorders (FAPD) in adults with variable results in pediatric studies. The study aims to evaluate the efficacy of amitriptyline in pediatric FAPD.
Methods:
In this open-label trial, children (≤ 18 years) diagnosed as FAPD based on ROME IV criteria were randomized to amitriptyline or placebo for 12 weeks. Post-treatment improvement of pain and quality of life (QOL) from the baseline were compared between the two groups.
Results:
The mean age of 149 children (amitriptyline 75, placebo 74) was 11.3 ± 3.5 years (79 boys). There was a significant difference in pain improvement in terms of reduction in scores for intensity (3.4 vs 0.9), frequency (3.6 vs 0.6), duration (3.5 vs 0.9), and QOL (2.3 vs 0.9) between amitriptyline and placebo group (P < 0.001 in all). Responders (> 50% reduction) in pain was seen in 76% in amitriptyline compared with 14.9% in the placebo group (P < 0.001). On multivariate analysis, the use of amitriptyline was the only factor predictive of response (odds ratio 24.1, 95% confidence interval: 9.1-64.6, P < 0.001). Minor adverse events were comparable between the groups (25.3% vs 13.5%, respectively, P = 0.07). Eighty-nine percent of children (24/27) who had extended treatment duration (6.8 ± 1.8 months) had pain improvement. After discontinuation of amitriptyline, 70% had sustained response over a mean follow up of 15.84 ± 5.6 months.
Conclusions:
A 3-month trial of amitriptyline gives sustained relief of pain in two-thirds of children with FAPD. The safety profile of the drug and its efficacy necessitate more frequent use in the clinical settings.
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