drugset / Trial / NCT04630834
Ibuprofen Plus Acetaminophen for Enhanced Pain Reduction
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Combination of analgesics with different modes of action have the potential to offer enhanced pain relief with reduced dosage. Ibuprofen and acetaminophen have different modes of action. Combination of ibuprofen and acetaminophen has shown enhanced analgesia in adult studies, with pediatric data limited to post-operative pain and dental pain. Our study objective is to evaluate the analgesic efficacy of oral acetaminophen plus ibuprofen versus ibuprofen plus placebo for the management of acute pain in a pediatric emergency department.
Timeline
- Start
- 2021-03-30
- Primary completion
- 2022-06-20
- Completion
- 2022-06-30
Publications
- Background Poddighe D, Brambilla I, Licari A, Marseglia GL. Ibuprofen for Pain Control in Children: New Value for an Old Molecule. Pediatr Emerg Care. 2019 Jun;35(6):448-453. doi: 10.1097/PEC.0000000000001505.
- Background Gaglani A, Gross T. Pediatric Pain Management. Emerg Med Clin North Am. 2018 May;36(2):323-334. doi: 10.1016/j.emc.2017.12.002.
- Background Jozwiak-Bebenista M, Nowak JZ. Paracetamol: mechanism of action, applications and safety concern. Acta Pol Pharm. 2014 Jan-Feb;71(1):11-23.
- Background Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
- Background Gazal G, Mackie IC. A comparison of paracetamol, ibuprofen or their combination for pain relief following extractions in children under general anaesthesia: a randomized controlled trial. Int J Paediatr Dent. 2007 May;17(3):169-77. doi: 10.1111/j.1365-263X.2006.00806.x.
- Background Motov S, Butt M, Masoudi A, Palacios W, Fassassi C, Drapkin J, Likourezos A, Hossain R, Brady J, Rothberger N, Flom P, Zerzan J, Marshall J. Comparison of Oral Ibuprofen and Acetaminophen with Either Analgesic Alone for Pediatric Emergency Department Patients with Acute Pain. J Emerg Med. 2020 May;58(5):725-732. doi: 10.1016/j.jemermed.2020.02.010. Epub 2020 Apr 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 15 mg/kg | Oral |
| Comparator | Ibuprofen | Small molecule | 10 mg/kg | Oral |
Indications
No indication recorded.