To compare two methods of pain relief after the surgery in children

A comparative study of analgesic efficacy of caudal Ropivacaine with clonidine or dexamethasone as adjuvants in paediatric infraumbilical surgeries â?? An open labelled Randomised control trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/08/015288

Enrollment

Registered

2018-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Analgesic efficacy of caudal Ropivacaine with dexamethasone: Caudal Ropivacaine 0.2% 1ml/kg and Dexamethasone 0.1mg/kg Control Intervention1: analgesic efficacy of caudal ropivacaine wi

Eligibility

Inclusion criteria

Inclusion criteria: • Age between 1 to 10 years • weight of child less than 30kg • American Society of Anesthesiologists (ASA) grade I and II patients • Children posted for infraumbilical surgeries less than 2 hour duration (herniotomy, urethroplasty,circumcision, orchidopexy, lower limb orthopaedic surgeries etc)

Exclusion criteria

Exclusion criteria: 1. Children posted for emergency surgery 2. Infection at the site of injection 3. Coagulopathy or on anticoagulation therapy 4. Congenital anomaly of lower spine and meninges 5. Active disease of the CNS 6. History of allergy to local anaesthetics, Clonidine and Dexamethasone 7. Surgeries in prone position

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of ropivacaine with clonidine or dexamethasone as adjuvants for caudal epidural block in paediatric infraumbilical surgeries.Timepoint: To evaluate duration of analgesia (defined as time from caudal injection until the first requirement of rescue analgesia, pain assessed by FLACC).	—

Secondary

Measure	Time frame
1. To assess haemodynamic stability between the two groups. 2. To assess incidence of any side effects like nausea and vomiting, sedation, bradycardia, hypotension, wound infection Timepoint: up to 12 hours postoperatively	—

Countries

India

Contacts

Public Contactkavyashree

Bangalore Baptist Hospital

kavyashree.daanu@gmail.com9141920884

Outcome results