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Role of dexamethasone in regional pain relief in children undergoing kidney surgery.

Comparison of intravenous and perineural Dexamethasone in Ultra-sound guided Paravertebral Block in Pediatric Patient Undergoing Open Pyeloplasty: A Prospective Double-Blinded Randomized Clinical Study.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014429
Enrollment
140
Registered
2018-06-05
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

Health Condition 1: null- healthy ASA 1 OR 2

Interventions

Intervention1: preservative free dexamethasone: preservative free dexamethasone 0.1 mg/kg maximum 4 mg into paravertebral space alone with 0.2% ropivacaine 0.5ml/kg into paravertebral space Control In

Sponsors

FLUID research grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children between 2 and 14 years posted for open pyeloplasty consented/ assented for study

Exclusion criteria

Exclusion criteria: 1. Patients with cutaneous infection at the site of needle puncture, 2. Pathology in the paravertebral space, 3. Allergy to local anesthetic drugs, 4. Obesity, 5. Coagulopathy, 6. Creatinine clearance less than 90 ml//min/1.73m2 7. Kyphoscoliosis 8. Diabetes mellitus 9. Malignancy 10. Psychiatric disorder 11. Immunocompromised child (HIV, already on dexamethasone, inflammatory disease)

Design outcomes

Primary

MeasureTime frame
comparing the efficacy and duration of the paravertebral blockTimepoint: Efficacy of the block will be assessed by calculating total analgesics requirement in both arms in morphine equivalents for 48 hours or till discharge from ward. Duration of the block will be assessed by calculating the time take from block administration to first rescue analgesia administered in minutes.

Secondary

MeasureTime frame
Incidence and severity scores of pains in recovery and surgical ward.FLACC (Face, Legs, Activity, Cry, Consolability) score for preverbal children and VAS(Visual Analogue Scale) score for verbal children.Timepoint: In the recovery ward pain score and rescue analgesia is needed will be noted, at time of arrival and every one hourly till discharge to the surgical ward. In the surgical ward pain score and rescue analgesia is needed will be noted, at the time of arrival and at least every 4th hourly for first 24 hours and at least every 6th hourly till discharge or till 48 hours. ;incidence of adverse events such as vascular puncture (blood aspirate),Abandoned block (unable to place),Failed block (completed but not successful),Respiratory: pneumothorax, respiratory depression, apnea other, Cardiovascular: arrhythmia, hypotension, cardiac arrest, otherTimepoint: within 48 hours from time of block administration or discharge from ward

Countries

India

Contacts

Public ContactAnita Shirley Joselyn

Christian Medical College, Vellore

anjeyanth@gmail.com7358377164

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026