Amitriptyline In Children Research Articles

Electrocardiograms changes in children with functional gastrointestinal disorders on low dose amitriptyline.

To study the effects of low dose amitriptyline on cardiac conduction in children. Secondary analysis of data obtained from a double-blind, randomized placebo-controlled trial, evaluating low dose amitriptyline in children with a diagnosis of functional abdominal pain, functional dyspepsia, and irritable bowel syndrome according to the Rome II criteria. Children 8-17 years of age were recruited from the pediatric gastroenterology clinics of 6 tertiary care centers in the United States. The electrocardiograms (EKGs) done prior to initiation of amitrityline and 1 mo after initiation of amitriptyline were examined. The changes in cardiac conduction were evaluated in patients and controls. Thirty children were included in the study. There were 12 patients, ages 9-17 years of both genders, in the amitriptyline treatment group and 18 patients, ages 9-17 years of both genders, in the placebo treatment group. None of the patients had any baseline EKG abnormality. Amitriptyline use was associated with an increase in heart rate (P = 0.024) and QTc interval (P = 0.0107) as compared to pre-EKGs. Children in the placebo group were also noted to present a statistically significant increase in QTc interval (P = 0.0498). None of the patients developed borderline QTc prolongation or long-QT syndrome after they were started on amitriptyline. The study findings suggest that once patients with functional gastrointestinal disorders have been screened for prolonged QTc interval on baseline EKG, they probably do not need a second EKG for reevaluation of cardiac conduction after starting low dose amitriptyline.

Accuracy of Pain Recall in Children

Chronic abdominal pain (AP) is common in children. Recall of symptoms is used clinically to determine management, to assess treatment progress, and in drug studies to assess outcomes. Limited data exist on accuracy of AP recall in children. The aim of the present study was to assess ability to accurately recall AP in children. The study was a secondary analysis of data obtained from a double-blind, randomized, placebo-controlled trial, evaluating amitriptyline in children with functional gastrointestinal disorders. Children ages 8 to 17 years with AP predominant functional gastrointestinal disorders based on Rome II criteria were recruited from 6 centers. Those with evidence of organic disease were excluded. Patients maintained AP diary daily for 1 month (presence, frequency, and intensity). At the end of the study, patients reported the number of days of AP during previous month. Agreement between daily pain reports and recalled pain was assessed. Univariate analysis was conducted with Spearman rank correlations. We recruited 63 children (45 girls, mean age 12.8 years). Sixteen percent children had perfect agreement on number of days of AP. Fifty-four percent of children recalled fewer episodes of pain. The average number of days with AP by recall was 17.7/month, whereas by diary it was 23.5/month (P = 0.001). Correlation between patient recall of the last week of symptoms (r = 0.47) was no better than correlation between recall of the last 30 days of symptoms (r = 0.48). On comparing AP recall versus various pain intensities, reported AP did not reflect only AP of greater severity. Higher correlation of recall of symptoms was seen in children 11 years or younger (r = 0.59) as compared with children older than 11 years (r = 0.26). Few children can accurately recall the episodes of AP. Children commonly recall a lower frequency of AP than that assessed by prospective diary reports. Reported recall does not reflect a shorter recollection period. Recall is not related to intensity of pain. Adolescents have worse recall of symptoms.

Significance of Screening Electrocardiogram Before the Initiation of Amitriptyline Therapy in Children With Functional Abdominal Pain

Amitriptyline (AMT) is commonly used in the management of children with irritable bowel syndrome. AMT is pro-arrhythmogenic and increases the risk of sudden cardiac death. However, there is not enough data regarding the cardiac toxicity in therapeutic doses of AMT in children and the need for screening electrocardiogram (EKG). Errors in computer EKG interpretation are not uncommon. In a risk-prevention study, the authors sought to identify the true incidence of prolonged corrected QT (QTc) interval and other arrhythmias in children with irritable bowel syndrome before the initiation of AMT. Out of the 760 EKGs screened, 3 EKGs demonstrated a true prolonged QTc after the careful manual reading by a pediatric cardiologist and they were not picked by computer-generated reading. The authors conclude that screening EKG should always be performed on children before initiating AMT therapy. Also, the computer-generated EKG needs to be verified by a pediatric cardiologist to avoid serious misinterpretations.

Cochrane Review: Antidepressants for the treatment of abdominal pain‐related functional gastrointestinal disorders in children and adolescents

Cochrane Review: Antidepressants for the treatment of abdominal pain‐related functional gastrointestinal disorders in children and adolescents

This Month in Gastroenterology

This Month in Gastroenterology

Multicenter, Randomized, Placebo-Controlled Trial of Amitriptyline in Children With Functional Gastrointestinal Disorders

There are no prospective, multicenter, double-blind, placebo-controlled, randomized pharmacologic trials for the treatment of pain-predominant functional gastrointestinal disorders in children. The aim of this study was to evaluate the efficacy of amitriptyline in children with pain-predominant functional gastrointestinal disorders. In this multicenter placebo-controlled trial, children with irritable bowel syndrome, functional abdominal pain, or functional dyspepsia were randomized to 4 weeks of placebo or amitriptyline (10 mg/d, weight <35 kg; 20 mg/d, weight >35 kg). Assessment of gastrointestinal symptoms, psychological traits, and daily activities occurred before and after intervention. Pain was assessed daily with self-report diaries. The primary outcome was overall response to treatment (child's assessment of pain relief and sense of improvement). Secondary outcomes were effect on psychosocial traits and daily functioning. Ninety children were enrolled, and 83 completed the study (placebo, 40 children [30 girls]; drug, 43 children [35 girls]). A total of 63% of patients reported feeling better and 5% feeling worse in the amitriptyline arm compared with 57.5% feeling better and 2.5% feeling worse in the placebo arm (P = .63). Pain relief was excellent in 7% and good in 38% of children receiving placebo compared with excellent in 15% and good in 35% of children treated with amitriptyline (P = .85). Logistic regression analysis of those reporting excellent or good response versus fair, poor, or failed response showed no difference between amitriptyline and placebo (P = .83). Children who had more severe pain at baseline in both groups (P = .0065) had worse outcome. Amitriptyline reduced anxiety scores (P < .0001). Both amitriptyline and placebo were associated with excellent therapeutic response. There was no significant difference between amitriptyline and placebo after 4 weeks of treatment. Patients with mild to moderate intensity of pain responded better to treatment.

Evaluation of the Efficacy of Amitriptyline in Children with Abdominal Pain of Non-Organic Origin

Purpose: Functional Abdominal pain (FAP) is common in children. Treatment is mostly empirical and not evidence based. Antidepressants are commonly used to treat FAP. To date there has been no prospective, multicenter double blind placebo (PL) controlled randomized trial in the treatment of FAP in children. Aim is to evaluate the effect of amitriptyline (AM) in children with FAP. Methods: Children from six tertiary care centers diagnosed with FAP (Rome II criteria) were randomized to 4 wks PL or low dose AM 10 mg/d in patients < 35 kg or 20 mg/d > 35 kg. Comprehensive evaluation of GI symptoms, psychological traits and ability to perform daily activities was conducted before and after intervention. Pain was assessed by daily diaries (visual analogue scale 1–100 mm). Primary outcome was overall response to treatment (child's assessment of pain relief and sense of improvement). Secondary outcomes included effect on psychosocial traits and ability to perform daily activity. Results: 90 children (mean 12.7, range 8–17 y) were enrolled, 83 completed the study (placebo: 40, 30 females; drug: 43, 35 females). 3 children (2 PL, 1 AM) discontinued for mild adverse events (fatigue, constipation, rash). Patients reported feeling better 63%, worse 5% in AM arm and feeling better 58%, worse 3% in PL arm (P= 0.85). Number needed to treat = 19. Absolute risk reduction = 5.3%. Pain relief was considered excellent (7%), good (39%) in children receiving AM and excellent (15%), good (35%) in PL (P= 0.85). Logistic regression analysis of patients reporting response to drug as excellent or good compared with those reporting fair, poor or failed showed no difference between AM and PL (P= 0.83). Correlation between overall assessment of pain at end of study and daily assessment of pain by daily diaries was moderate (r = 0.45, P < 0.0001). Worse outcome was associated with baseline: 1) pain > 60 mm in both groups (P= 0.0065), 2) higher depression scores (P < 0.0001). Age and gender had no effect on outcome. Conclusion: There was > 50% improvement in abdominal pain in children receiving AM. There was no significant difference compared to placebo after 4 weeks of treatment. Patients with mild to moderate intensity of pain responded better to therapy. Those who had higher depression scores at baseline correlated negatively with sense of improvement.Table

Amitriptyline in Children with Major Depressive Disorder: A Double-Blind Crossover Pilot Study

This study reports the effect of amitriptyline and placebo in nine prepubertal depressed children in a double-blind crossover design. The children were assigned randomly to placebo or amitriptyline for 4 weeks and then were switched to the other. Results indicate that amitriptyline may have a place in the treatment of childhood depression.

AMITRIPTYLINE AND METHYLPHENIDATE TREATMENT OF BEHAVIORALLY DISORDERED CHILDREN

SUMMARYA controlled investigation was conducted to assess the relative effectiveness of amitriptyline and methylphenidate for treating hyperactive/aggressive behavior in children originally referred to a learning clinic. Behavioral change was measured through parent and teacher ratings. Drug effects on attention, short term memory, and impulsivity were evaluated with laboratory tasks. It was found that both drugs were largely comparable in attenuating hyperactivity and aggression. Of the laboratory measures, only attention was improved by both drugs. However, neither medication interfered with functioning on the other laboratory tests. With the exception of and trip by line‐induced sedation, side effects were of minor degree. Findings raised questions concerning measuring and improving attentiveness. Differences between results of this and other studies were discussed, as were issues regarding pharmacotherapy with amitriptyline in children.