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comparison of 2 routes of dexmedetomidine for pain relief in children undergoing infraumbilical surgeries

A comparative study to evaluate the analgesic efficacy and safety of caudal versus intranasal dexmedetomidine as an adjuvant to caudal ropivacaine in paediatric patients undergoing infraumbilical surgeries : A Double blind randomised controlled study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045492
Enrollment
63
Registered
2022-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Intranasal dexmedetomidine: Group N- will receive intranasal dexmedetomidine 1 mcg/kg
undiluted parenteral preparation (100mcg/ml), equally divided volume instilled into both nostrils after giving general anesthesia Control Intervention1: caudal block: Group C- will receive 1 mcg/kg de

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patient Aged 1-8 years, ASA physical status I/II, undergoing infraumbilical surgeries under general anaesthesia

Exclusion criteria

Exclusion criteria: 1. Parental /guardian refusal for inclusion in the study 2. Known allergy to amide local anaesthetics or dexmedetomidine. 3. Pre-existing cardiovascular, respiratory or neurological disease 4. History of developmental delay or mental retardation which could make observational pain intensity assessment difficult 5. Children with conduction blocks 6. Known or suspected coagulopathy 7. Anatomical abnormalities of spine and sacrum. 8. Local infection at caudal puncture site 9. Rhinitis and nasal polyp 10. Patients with age 7 years 11. ASA grade III/IV

Design outcomes

Primary

MeasureTime frame
To compare the duration of postoperative analgesia ie. the time when the first analgesic is required postoperativelyTimepoint: Immediate postoperative to over 24 hours after surgery

Secondary

MeasureTime frame
To compare the following parameters between 2 groups 1. Postoperative emergence delirium using WATCHA score 2. Postoperative sedation using 4-point sedation score 3. Modified Aldrete score 6 hrs postoperatively 4. Total analgesic consumption in first 24 hrs 5. Incidence of side effects like bradycardia , hypotension , nausea-vomiting and desaturation, urinary retention Timepoint: 24 hrs postoperatively

Countries

India

Contacts

Public ContactAyushi Agarwal

All India Institute of Medical Sciences,New Delhi

shreyabs@hotmail.com9892652781

Outcome results

None listed

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