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COMPARISON OF A LOCAL ANAESTHETIC ALONE AND IN COMBINATION WITH AN ANALGESIC AND AN ANTIHYPERTENSIVE DRUG FOR POSTOPERATIVE PAIN RELIEF IN CHILDREN VIA CAUDAL ROUTE.

A comparative study of levobupivacaine, levobupivacaine with ketamine and levobupivacaine with dexmedetomidine in caudal block for post operative pain relief in paediatric patients.

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009902
Enrollment
90
Registered
2017-09-25
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- AMERICAN SOCIETY OF ANAESTHESIOLOGY GRADE 1 AND 2

Interventions

Intervention1: LEVOBUPIVACAINE WITH KETAMINE: LEVOBUPIVACAINE 0.25% AT A DOSE OF 0.75MILILITER/KG OF BODY WEIGHT WITH KETAMINE 0.05% AT A DOSE OF 0.5 MILIGRAM/KG BODY WEIGHT Intervention2: LEVOBUPIVAC

Sponsors

INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.PATIENTS OF ASA PHYSICAL STATUS 1 AND 2. 2.PATIENTS BETWEEN 3 MONTH TO 7 YEARS OF AGE OF EITHER SEX. 3.PARENTS ABLE TO COMPREHEND TO PARTICIPATE. 4.PATIENTS IN WHOM LEVOBUPIVACAINE IS INDICATED FOR CAUDAL BLOCK.

Exclusion criteria

Exclusion criteria: 1.PARENTS REFUSAL TO PARTICIPATE. 2.CONTRAINDICATION TO USE OF KETAMINE OR DEXMEDETOMIDINE. 3.PATIENTS WITH KNOWN SENSITIVITY TO LEVOBUPIVACAINE,KETAMINE OF DEXMEDETOMIDINE. 4.PATIENTS ON CONCOMITANT ANALGESIC OR SEDATIVE MEDICATION. 5.PATIENTS WITH PRESENCE OF INFECTION AT THE SITE OF CAUDAL BLOCK,COGULOPATHY OR ANY NEUROLOGICAL ILLNESS.

Design outcomes

Primary

MeasureTime frame
POST OPERATIVE PAIN RELIEF BY FLACC SCORE.Timepoint: 15 MINUTES, 45 MINUTES, 75 MINUTES, 125 MINUTES, 155 MINUTES, 185 MINUTES, 215 MINUTES, 275 MINUTES, 335 MINUTES.

Secondary

MeasureTime frame
SEDATION, NAUSEA VOMITING, RESPIRATORY DEPRESSION, URINARY RETENTION.Timepoint: 15 MINUTES, 45 MINUTES, 75 MINUTES, 125 MINUTES, 155 MINUTES, 185 MINUTES, 215 MINUTES, 275 MINUTES, 335 MINUTES.

Countries

India

Contacts

Public ContactPRAKASH KUMAR DUBEY

INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES

PKDUBEY@HOTMAIL.COM

Outcome results

None listed

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