Caudal Ropivacaine With or Without Dexmedetomidine for Post Operative Analgesia

NCT05979558 | Completed

• 1 other identifier: NamsNepal
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the postoperative analgesic effects of caudal Ropivacaine with or without Dexmedetomidine in pediatric infraumbilical surgery. The main question\[s\] it aims to answer are: • if Caudal Dexmedetomidine with Ropivacaine would prolong the duration of analgesia in children undergoing infraumbilical surgery. Participants will receive ropivacaine with dexmedetomidine in infraumbilical surgery. If there is a comparison group: Investigators will compare this with ropivacaine with a placebo to see if the duration of analgesia differs.

Conditions

Ropivacaine; Infraumbilical Surgery; Dexmedetomidine; Analgesia

Keywords

ropivacaine; caudal ropivacaine; dexmedetomidine; placebo; analgesia; infraumbilical surgery

Outcome Measures

Primary Outcomes (3)

• Duration of analgesia:

  The primary outcome will be the duration of analgesia defined as the time period between administration of study drugs to first need of rescue analgesia when until the time of rFLACC score (revised Face, Legs, Activity, Cry, and Consolability) reached ≥4.

  upto first 24 hour after intervention

• Post-operative pain Assessment (rFLACC score) rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)

  Each of the five categories F (face), L (legs), A (Activity), C (Cry), C (Consolability) will be scored from 0 to 2 which results total score in between zero and ten.

  first 24 hour after intervention

• Total analgesics consumption in first 24 hours postoperative period

  If r-FLACC pain score ≥4 at any time, an injection Paracetamol 15mg/kg will be given. If the r-FLACC pain score still ≥4 after 30 minutes of injection Paracetamol, then the child will treated with an injection Pethidine 0.5mg/kg. After that, an injection Paracetamol at 15mg/kg will be given 6 hourly. Total analgesic consumption in the first 24 hours will be calculated by adding the total analgesic consumed in 24 hours after the intervention.

  first 24 hours after intervention

Secondary Outcomes (1)

• Side effects of study drugs

  monitored for 24 hours and treated accordingly

Study Arms (2)

Ropivacaine with dexmedetomidine

EXPERIMENTAL

Drug: ropivacaine with dexmedetomidine

Ropivacaine with Normal Saline

PLACEBO COMPARATOR

Drug: Ropivacaine with placebo

Interventions

ropivacaine with dexmedetomidine DRUG

this group received with ropivacaine with dexmedetomidine

Ropivacaine with dexmedetomidine

Ropivacaine with placebo DRUG

this group received with ropivacaine with normal saline

Ropivacaine with Normal Saline

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of either sex aged 2-7 years
• ASA (American Society of Anesthesiologist) physical status I or II
• Patients undergoing elective infraumbilical surgeries

You may not qualify if:

• History of neuromuscular or psychiatric disease
• Coagulation disorders
• Skin lesion at the site of injection
• Spine deformity
• History of developmental delay
• Allergy to study drugs

Sponsors & Collaborators

• National Academy of Medical Sciences, Nepal: lead

Study Sites (1)

National Academy of Medical Sciences (NAMS)

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kaushal Tamang, MBBS,MD

  NAMS

  PRINCIPAL INVESTIGATOR

• Bidur K Baral, MBBS,MD

  NAMS

  STUDY CHAIR

• Sadichhya S Malla, MBBS,MD

  Kanti Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Children were randomly assigned to two groups having 31 children in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Children were randomly assigned to two groups having 31 children in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 7, 2023
• Study Start: June 16, 2020
• Primary Completion: June 10, 2021
• Study Completion: December 10, 2021
• Last Updated: August 7, 2023

Record last verified: 2023-07

Locations

NE (1)