drugset / Trial / NCT03781505
Intravenous Paracetamol in Combination With Caudal Ropivacaine
RandomizedParallel-groupTriple-blindTreatment
Summary
To investigate whether the addition of intravenous paracetamol with caudal ropivacaine leads to better quality of postoperative recovery in patients undergoing hypospadius repair than caudal ropivacaine alone. The quality of recovery will be judged by postoperative analgesia requirement and lesser agitation in the postoperative period.
Timeline
- Start
- 2019-01-31
- Primary completion
- 2022-04-30
- Completion
- 2022-05-01
Publications
- Background Hosseini Jahromi SA, Sadeghi Poor S, Hosseini Valami SM, Javadi A. Effects of suppository acetaminophen, bupivacaine wound infiltration, and caudal block with bupivacaine on postoperative pain in pediatric inguinal herniorrhaphy. Anesth Pain Med. 2012 Spring;1(4):243-7. doi: 10.5812/aapm.3551. Epub 2012 Apr 1.
- Background Samuel M, Hampson-Evans D, Cunnington P. Prospective to a randomized double-blind controlled trial to assess efficacy of double caudal analgesia in hypospadias repair. J Pediatr Surg. 2002 Feb;37(2):168-74. doi: 10.1053/jpsu.2002.30247.
- Background Mercan A, Sayin MM, Saydam S, Ozmert S, Tiryaki T. When to add supplemental rectal paracetamol for postoperative analgesia with caudal bupivacaine in children? A prospective, double-blind, randomized study. Paediatr Anaesth. 2007 Jun;17(6):547-51. doi: 10.1111/j.1460-9592.2006.02141.x.
- Background Ozyuvaci E, Altan A, Yucel M, Yenmez K. Evaluation of adding preoperative or postoperative rectal paracetamol to caudal bupivacaine for postoperative analgesia in children. Paediatr Anaesth. 2004 Aug;14(8):661-5. doi: 10.1111/j.1460-9592.2004.01255.x.
- Background Ozbek H, Bilen A, Ozcengiz D, Gunes Y, Ozalevli M, Akman H. The comparison of caudal ketamine, alfentanil and ketamine plus alfentanil administration for postoperative analgesia in children. Paediatr Anaesth. 2002 Sep;12(7):610-6. doi: 10.1046/j.1460-9592.2002.00913.x.
- Background Gunter JB. Benefit and risks of local anesthetics in infants and children. Paediatr Drugs. 2002;4(10):649-72. doi: 10.2165/00128072-200204100-00003.
- Background Mohammed BS, Engelhardt T, Cameron GA, Cameron L, Hawksworth GM, Hawwa AF, McElnay J, Helms PJ, McLay JS. Population pharmacokinetics of single-dose intravenous paracetamol in children. Br J Anaesth. 2012 May;108(5):823-9. doi: 10.1093/bja/aes025. Epub 2012 Mar 1.
- Background Perrott DA, Piira T, Goodenough B, Champion GD. Efficacy and safety of acetaminophen vs ibuprofen for treating children's pain or fever: a meta-analysis. Arch Pediatr Adolesc Med. 2004 Jun;158(6):521-6. doi: 10.1001/archpedi.158.6.521.
- Background Prins SA, Van Dijk M, Van Leeuwen P, Searle S, Anderson BJ, Tibboel D, Mathot RA. Pharmacokinetics and analgesic effects of intravenous propacetamol vs rectal paracetamol in children after major craniofacial surgery. Paediatr Anaesth. 2008 Jul;18(7):582-92. doi: 10.1111/j.1460-9592.2008.02619.x. Epub 2008 May 8.
- Background Nnaji CT, Onajin-Obembe B, Ebirim L. The analgesic effects of rectal diclofenac versus rectal paracetamol following caudal-bupivacaine for pediatric day-case inguinal herniotomies: a randomized controlled prospective trial. J Pediatr Surg. 2017 Sep;52(9):1384-1388. doi: 10.1016/j.jpedsurg.2017.05.001. Epub 2017 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 15 mg/kg | Intravenous |
| Background | Ropivacaine | Other / unclassified | 0.25 % | Other |
Indications
No indication recorded.