LO36: Hyoscine butylbromide (Buscopan) for abdominal pain in children: a randomized controlled trial

CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S20
Author(s):  
N. Poonai ◽  
S. Elsie ◽  
K. Kumar ◽  
K. Coriolano ◽  
S. Brahmbhatt ◽  
...  
Keyword(s):  
Abdominal Pain ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Common Adverse Effect ◽  
Functional Abdominal Pain ◽  
Hyoscine Butylbromide ◽  
Caregiver Satisfaction ◽  
Intention To Treat ◽  
Pain Scores ◽  
The Mean

Introduction: Abdominal pain is one of the most frequent reasons for an emergency department (ED) visit. Most cases are functional and no therapy has proven effective. Our objective was to determine if hyoscine butylbromide (HBB) (BuscopanTM) is effective for children who present to the ED with functional abdominal pain. Methods: We conducted a randomized, blinded, superiority trial comparing HBB 10 mg plus acetaminophen placebo to oral acetaminophen 15 mg/kg (max 975 mg) plus HBB placebo using a double-dummy approach. We included children 8-17 years presenting to the ED at London Health Sciences Centre with colicky abdominal pain rated >40 mm on a 100 mm visual analog scale (VAS). The primary outcome was VAS pain score at 80 minutes post-administration. Secondary outcomes included adverse effects; caregiver satisfaction with pain management using a five-item Likert scale; recidivism and missed surgical diagnoses within 24-hours of discharge. Analysis was based on intention to treat. Results: We analyzed 225 participants (112 acetaminophen; 113 HBB). The mean (SD) age was 12.4 (3.0) years and 148/225 (65.8%) were females. Prior to enrollment, the median (IQR) duration of pain prior was 2 (4.5) hours and analgesia was provided to 101/225 (44.9%) of participants. The mean (SD) pre-intervention pain scores in the acetaminophen and HBB groups were 62.7 (15.9) mm and 60.3 (17.3) mm, respectively. At 80 minutes, the mean (SD) pain scores in the acetaminophen and HBB groups were 30.1 (28.8) mm and 29.4 (26.4) mm, respectively and there were no significant differences adjusting for pre-intervention scores (p = 0.96). The median (IQR) caregiver satisfaction was high in the acetaminophen [5 (2)] and HBB [5 (1)] groups (p = 0.79). The median (IQR) length of stay between acetaminophen [235 (101)] and HBB [234 (103)] was not significantly different (p = 0.53). The proportion of participants with a return visit for abdominal pain was 4/112 (3.5%) in the acetaminophen group and 6/113 (5.3%) in the HBB group. The most common adverse effect was nausea (9% in each group) and there were no significant differences in adverse effects between acetaminophen (26/112, 23.2%) and HBB (31/113, 27.4%) (p = 0.52). There were no missed surgical diagnoses. Conclusion: For children with presumed functional abdominal pain who present to the ED, both acetaminophen and HBB produce a clinically important (VAS < 30 mm) reduction in pain and should be routinely considered in this clinical setting.

scholarly journals Mebeverine for Pediatric Functional Abdominal Pain: A Randomized, Placebo-Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Zahra Pourmoghaddas ◽  
Hossein Saneian ◽  
Hamidreza Roohafza ◽  
Ali Gholamrezaei
Keyword(s):  
Abdominal Pain ◽  
Protocol Analysis ◽  
Response Rate ◽  
Controlled Trial ◽  
Pain Scale ◽  
Functional Abdominal Pain ◽  
Intention To Treat ◽  
Point Reduction ◽  
Significant Difference ◽  
Larger Sample

We evaluated the effectiveness of an antispasmodic, mebeverine, in the treatment of childhood functional abdominal pain (FAP). Children with FAP (n = 115, aged 6–18 years) received mebeverine (135 mg, twice daily) or placebo for 4 weeks. Response was defined as ≥2 point reduction in the 6-point pain scale or “no pain.” Physician-rated global severity was also evaluated. Patients were followed up for 12 weeks. Eighty-seven patients completed the trial (44 with mebeverine). Per-protocol and intention-to-treat (ITT) analyses were conducted. Treatment response rate in the mebeverine and placebo groups based on per-protocol [ITT] analysis was 54.5% [40.6%] and 39.5% [30.3%] at week 4 (P = 0.117[0.469]) and 72.7% [54.2%] and 53.4% [41.0] at week 12, respectively (P = 0.0503[0.416]). There was no significant difference between the two groups in change of the physician-rated global severity score after 4 weeks (P = 0.723) or after 12 weeks (P = 0.870) in per-protocol analysis; the same results were obtained in ITT analysis. Mebeverine seems to be effective in the treatment of childhood FAP, but our study was not able to show its statistically significant effect over placebo. Further trials with larger sample of patients are warranted.

scholarly journals Effect of a Low-fodmap Diet for the Management of Functional Abdominal Pain Disorders in Children: A Study Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Agata Stróżyk ◽  
Andrea Horvath ◽  
Jane Muir ◽  
Hania Szajewska
Keyword(s):  
Randomized Controlled Trial ◽  
Abdominal Pain ◽  
Controlled Trial ◽  
Well Being ◽  
World Health ◽  
Reliable Change Index ◽  
Functional Abdominal Pain ◽  
Regular Diet ◽  
Randomized Controlled ◽  
Fodmap Diet

Abstract Background Evidence from studies in adults documents that fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may be triggers of symptoms in individuals with functional abdominal pain disorders (FAPDs). However, in children, the evidence is very limited. We aim to assess the effects of a low-FODMAP diet compared with a regular diet for the management of children with FAPDs. Methods We will perform a randomized, quadruple-blinded, controlled trial. Seventy-four children aged 8 to 18 years with a FAPD (Irritable Bowel Syndrome or Functional Abdominal Pain-Not Otherwise Specified), diagnosed according to the Rome IV criteria, will be randomly allocated to receive either a low-FODMAP diet or a regular diet for 4 weeks. The primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a Visual Analogue Scale (VAS) during the last week of the trial compared with baseline, that is at least equal to the Reliable Change Index (≥ 25 mm change on VAS). Other outcomes will include changes in stool consistency, abdominal pain frequency, total scores on the Gastrointestinal Symptom Rating Scale, KIDSCREEN-10 Index and World Health Organization Five Well-Being Index, child’s school attendance and parents’ work absenteeism, and BMI-for-age z-score. Compliance, tolerability of the low-FODMAP diet, and adverse events also will be evaluated. Each FAPD subtype will be assessed separately.DiscussionThere is a need for high-quality evidence regarding the dietary management of children with FAPDs. This randomized controlled trial (RCT) of rigorous methodological design will help to establish the effectiveness, if any, of a low-FODMAP diet for the management of FAPDs in the pediatric population. The findings of this RCT will assist with the development of guidelines and influence the direction of further research. Trial registration: NCT04528914

scholarly journals Randomized Controlled Trial between Levetiracetam and Phenobarbital in the Treatment of Neonatal Seizure due to Perinatal Asphyxia

2018 ◽  
Vol 42 (2) ◽  
pp. 67-72
Author(s):  
Abu Faisal Md Pervez ◽  
Md Fakhrul Amin Badal ◽  
SM Nurun Nabi ◽  
Mohammad Kamrul Hassan Shabuj ◽  
Sanjoy Kumer Dey ◽  
...  
Keyword(s):  
Adverse Effect ◽  
Randomized Controlled Trial ◽  
Adverse Effects ◽  
Perinatal Asphyxia ◽  
Controlled Trial ◽  
Common Adverse Effect ◽  
Neonatal Seizure ◽  
College Hospital ◽  
Antiepileptic Agent ◽  
Randomized Controlled

Background: Seizure occurs more frequently in neonatal period and incidence of seizure is 50%-68% in perinatal asphyxia. At present phenobarbital is the drug of choice for treating neonatal seizure, which has some adverse effects on neurodevelopment status. Levetiracetam is a novel antiepileptic agent well-tolerated and effective in focal, generalized and neonatal seizure as well and lacks the adverse effects like phenobarbital. The present study was undertaken to compare the safety and efficacy of levetiracetam to phenobarbital in the treatment of neonatal seizure due to perinatal asphyxia.Methodology: This interventional study (Randomized Controlled Trial) was conducted in Department of Neonatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka and Dhaka Medical College Hospital, Dhaka, Bangladesh from 1st January’ 2014 to 30th June’ 2015. Intravenous levetiracetam injection, 50 mg/kg loading followed by 10 mg/kg 8 hourly maintenance was used and phenobarbital intravenous 20-40 mg/kg loading and 2.5 mg/kg/dose 12 hourly maintenance was given as per institutional protocol.Results: Sixty-nine term asphyxiated neonates (intention to treat population) provided analyzable data. Seizure control was found significantly higher (p = 0.011) higher in levetiracetam group in comparison to phenobarbital group (71% vs 40%). Need for more than one drug was significantly lower in levetiracetan group (p=0.011). Adverse effects were found significantly (p=0.001) lower in levetiracetam group (9% vs 43%). No serious adverse effect was observed in any group and most common adverse effect was somnolence in both group followed by irritability. Restlessness, sedation and shallow breathing were found only in phenobarbital group.Conclusion: Levetiracetam is more effective and safe in comparison to phenobarbital in the treatment of neonatal seizure due to perinatal asphyxia.Bangladesh J Child Health 2018; VOL 42 (2) :67-72

Cognitive Behavior Therapy for Pediatric Functional Abdominal Pain: A Randomized Controlled Trial

PEDIATRICS ◽  
2013 ◽  
Vol 132 (5) ◽  
pp. e1163-e1172 ◽  
Author(s):  
Shelley M.C. van der Veek ◽  
Bert H.F. Derkx ◽  
Marc A. Benninga ◽  
Frits Boer ◽  
Else de Haan
Keyword(s):  
Randomized Controlled Trial ◽  
Abdominal Pain ◽  
Behavior Therapy ◽  
Cognitive Behavior Therapy ◽  
Controlled Trial ◽  
Cognitive Behavior ◽  
Functional Abdominal Pain ◽  
Randomized Controlled

scholarly journals Dance and yoga reduced functional abdominal pain in young girls: A randomized controlled trial

2021 ◽  
Author(s):  
Sofie Högström ◽  
Anna Philipson ◽  
Lars Ekstav ◽  
Mats Eriksson ◽  
Ulrika L. Fagerberg ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Abdominal Pain ◽  
Controlled Trial ◽  
Functional Abdominal Pain ◽  
Young Girls ◽  
Randomized Controlled

Hypnotherapy for Children With Functional Abdominal Pain or Irritable Bowel Syndrome: A Randomized Controlled Trial

2007 ◽  
Vol 133 (5) ◽  
pp. 1430-1436 ◽  
Author(s):  
Arine M. Vlieger ◽  
Carla Menko–Frankenhuis ◽  
Simone C.S. Wolfkamp ◽  
Ellen Tromp ◽  
Marc A. Benninga
Keyword(s):  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Controlled Trial ◽  
Functional Abdominal Pain ◽  
Randomized Controlled ◽  
Irritable Bowel

scholarly journals Gallbladder motility in children with chronic functional abdominal pain

2019 ◽  
Vol 6 (5) ◽  
pp. 2042
Author(s):  
Raaghul C. ◽  
Rajesh N. T. ◽  
Vikrant Kanagaraju ◽  
Bharathi Elangovan
Keyword(s):  
Abdominal Pain ◽  
Ejection Fraction ◽  
Gall Bladder ◽  
Chronic Abdominal Pain ◽  
Gallbladder Motility ◽  
P Value ◽  
Functional Abdominal Pain ◽  
Rome Iii ◽  
The Mean ◽  
Upper Abdominal

Background: Chronic abdominal pain is a common gastrointestinal symptom in children that significantly lowers their quality of life. In adults, Gall bladder (GB) hypomotility / dyskinesia is associated with many functional abdominal disorders but there is scarcity of evidence on its role in childhood gastro-intestinal disorders. Aim of the study is to evaluate the GB motility in children with chronic functional abdominal pain (FAP).Methods: Children aged 5-15 years with chronic abdominal pain fulfilling ROME-III criteria and healthy controls were included and all study participants were subjected to ultrasonographic evaluation of the gall bladder volume in fasting state and post - Fatty test meal (FTM) and its ejection fraction was calculated.Results: Sixtysix children including 31 with chronic FAP underwent sonographic evaluation for GB motility. The mean ejection fraction (EF) of cases and controls were 51.72±17.76% and 57.3±23.26% (p value - 0.158). The mean EF of cases with upper abdominal pain and lower/peri-umbilical abdominal pain were 41.7±17.1% and 57.2±15.9% respectively (p value < 0.0001). Increasing BMI had no significant association with GB motility among the participants.Conclusions: There is lack of significant association between children with chronic FAP and GB hypomotility. Children with upper abdominal pain have lesser GB EF, suggesting a possible abnormal GB motility.

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