Children Clinical Trial
Official title:
Hyoscine Hydrobromide (Buscopan) Versus Acetaminophen for Acute Abdominal Pain in Children: A Randomized Controlled Trial
Verified date | April 2019 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There is ample evidence that pain in children is under recognized and under treated. This is especially true for acute abdominal pain, a common complaint in the paediatric emergency department. Clinicians often fear that analgesia will obscure the diagnosis of a potentially surgical condition. As a result, acute abdominal pain goes untreated in many children, as there is no standard of care. Hyoscine N-butylbromide (Buscopan) has been used successfully in adults and children for pain associated with urinary tract infections and kidney stones for over 60 years. However, no study has explored its usefulness in relieving acute abdominal pain in children. The objectives of this study are to investigate to what degree Buscopan is effective in relieving abdominal pain in children compared to acetaminophen.
Status | Completed |
Enrollment | 236 |
Est. completion date | February 22, 2019 |
Est. primary completion date | December 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility |
Inclusion Criteria: - All children aged 8-17 years presenting to the paediatric ED with: 1. A chief complaint of colicky abdominal pain AND 2. Pain score of at least 4/10 on the Faces Pain Scale - Revised AND 3. A presumed non-surgical etiology Exclusion Criteria: 1. Prior abdominal surgery 2. Concomitant use of other anticholinergic medication including but not limited to tricyclic antidepressants, antihistamines, benztropine mesylate 3. Signs and symptoms consistent with a bowel obstruction 4. Peritoneal signs 5. Suspected previous hypersensitivity reaction to either acetaminophen or HBB 6. Suspected appendicitis 7. History of abdominal trauma within 48 hours of presentation 8. Unstable vital signs 9. History of bowel obstruction 10. Myasthenia gravis 11. Fever (aural temperature > 38.2 C) 12. Chronic liver disease 13. Persistent vomiting despite administration of oral anti-emetic 14. Symptoms and signs consistent with a urinary tract infection 15. Symptoms and signs consistent with a toxin ingestion 16. Symptoms and signs consistent with gynecological or gonadal pathology 17. Symptoms and signs consistent with vasoocclusive crisis in a patient with a hemoglobinopathy |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analgesic Efficacy | Pain severity on a 100 mm Visual Analog Scale (VAS) | 80 minutes post-intervention | |
Secondary | Analgesic Efficacy | Pain severity on Faces Pain Scale - Revised and VAS | 15 minutes post-intervention | |
Secondary | Analgesic Efficacy | Pain severity on Faces Pain Scale - Revised and VAS | 30 minutes post-intervention | |
Secondary | Analgesic Efficacy | Pain severity on Faces Pain Scale - Revised and VAS | 45 minutes post-intervention | |
Secondary | Analgesic Efficacy | Pain severity on Faces Pain Scale - Revised and VAS | 60 minutes post-intervention | |
Secondary | Need for Rescue Analgesia | Frequency of rescue analgesia | 80 minutes post-intervention | |
Secondary | Time to Analgesia | Time to Achieve 20% Reduction in Faces Pain Score - Revised from time 0 | 80 minutes post-intervention | |
Secondary | Adequacy of Sedation | Proportion of participants that achieve a pain score < 30 mm on the VAS | 80 minutes post-intervention | |
Secondary | Adverse Effects | Frequency of Adverse Effects | 80 minutes post-intervention | |
Secondary | Caregiver Satisfaction | Satisfaction scores on 5-Item Likert Scale | 80 minutes post-intervention | |
Secondary | Return visits | Proportion of participants with return visits for surgical pathology | 72 hours post discharge |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03563196 -
Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
|
||
Completed |
NCT02553486 -
Internationally Adopted Children Quality of Life
|
N/A | |
Completed |
NCT02918890 -
Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
|
N/A | |
Completed |
NCT02903134 -
Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity
|
||
Active, not recruiting |
NCT01874847 -
PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin
|
Phase 2/Phase 3 | |
Enrolling by invitation |
NCT01971840 -
Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.
|
N/A | |
Enrolling by invitation |
NCT01971827 -
Effectiveness of a Physical Activity Intervention to Prevent Obesity and Improve Academic Performance
|
N/A | |
Completed |
NCT01738308 -
The Effects of Healing Touch on Post Operative Pediatric Patients
|
N/A | |
Completed |
NCT01864811 -
Effect of Baby-CIMT in Infants Younger Than 12 Months
|
N/A | |
Completed |
NCT01693926 -
Effect of Physical Activity an Stress in Children
|
N/A | |
Completed |
NCT01943760 -
Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty
|
Phase 4 | |
Completed |
NCT01323010 -
Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes
|
N/A | |
Completed |
NCT01277224 -
Effectiveness of a Physical Activity Intervention on the Obesity of Schoolchildren
|
N/A | |
Active, not recruiting |
NCT00989547 -
Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)
|
Phase 1 | |
Completed |
NCT04051723 -
Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children
|
Phase 4 | |
Completed |
NCT03236363 -
Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!
|
N/A | |
Completed |
NCT03236337 -
Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!
|
N/A | |
Not yet recruiting |
NCT03427697 -
Effect of VR and Accommdation Relax on Controlling Myopia in Children
|
N/A | |
Completed |
NCT05603507 -
Inspiratory Muscle Training in Children With Chest Burn
|
N/A | |
Not yet recruiting |
NCT06267339 -
Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents
|
Early Phase 1 |