Intravenous Paracetamol in Combination With Caudal Ropivacaine

NCT03781505 | Completed Phase 4 Results DMC

• 1 other identifier: 5445-Ane-ERC-18
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Analgesia Requirement

  The requirement of postoperative analgesia of the patient will be evaluated by using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). This scale has 5 domains. It includes crying, facial expression, verbal response, touching the wound and torso and leg movement. It is a behavioural scale and measures each domain on a numerical scale of 0 to 2. Minimum score is 0 while maximum score is 10. Aggregate score will be added. Score less than 4 will be consider adequate analgesia while score greater than 4 will be consider inadequate analgesia. CHEOPS Pain Score less than four in participants of C and P groups will be reported at different time points.

  follow till 6 hours postoperatively

Secondary Outcomes (1)

• Sedation

  follow till 4 hours postoperatively

Study Arms (2)

Intravenous paracetamol with Caudal Ropivacaine

EXPERIMENTAL

Paracetamol is widely accepted and most commonly used as an adjuvant for postoperative analgesia. It also improves the quality of recovery by attenuating the pain associated with the surgical position. Adverse effects associated with the paracetamol are rare \<1/10000, which includes malaise, increased level of hepatic transaminases and hypersensitivity reaction. It has been studied in combination with caudal analgesia with bupivacaine through the rectal route 7,8 with variable results. Caudal anaesthesia is effective in alleviating pain below the umbilicus. Also if the caudal block is administered at the beginning of surgery, the effect will start wearing off 2 to 3 hours post surgery. Administration of paracetamol towards end of surgery may help with both these issues. In this study we aim to investigate the effect of adding intravenous paracetamol in combination with caudal analgesia with ropivacaine, hoping that it may improve quality of postoperative analgesia and recovery.

Drug: Paracetamol +caudal ropivacaine

Placebo

PLACEBO COMPARATOR

Intravenous Normal Saline with Caudal Ropivacaine

Drug: Placebo

Interventions

Paracetamol +caudal ropivacaine DRUG

Paracetamol + Ropivacaine

Intravenous paracetamol with Caudal Ropivacaine

Placebo DRUG

Caudal ropivacaine

Placebo

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3-10 years
• ASA (American Society of Anesthesiologists) I and II
• Undergoing hypospadias repair surgery

You may not qualify if:

• Coagulopathy
• Aspirin or any other analgesic ingestion in the preceding week
• Preexisting neurological or spinal disease
• Hepatic, renal disease and malnutrition
• Severe hypovolemia
• Uncontrolled convulsions
• Refusal of the parents
• Local Skin infection at the puncture site
• Allergy to local anesthetics
• Patient previously involved in other studies

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (10)

• 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.

  PMID: 24904808 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.

  PMID: 11819193 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.

  PMID: 17498016 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.

  PMID: 15283825 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.

  PMID: 12358657 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.

  PMID: 12269841 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.

  PMID: 22389380 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.

  PMID: 15184213 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.

  PMID: 18482233 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.

  PMID: 28535959 BACKGROUND

Results Point of Contact

• Title: Dr. Muhammad Saad Yousuf
• Organization: Aga Khan University

saad.yousuf@aku.edu

+92213486

Study Officials

• Muhammad S Yousuf, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control trail

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: December 20, 2018
• Study Start: January 31, 2019
• Primary Completion: April 30, 2022
• Study Completion: May 1, 2022
• Last Updated: August 16, 2024
• Results First Posted: August 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)