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Compare two drug combinations for pain relief in pediatric patients after surgery

Comparative Study between Bupivacaine Plus Fentanyl and Bupivacaine Plus Dexmedetomidine for epidural caudal analgesia in Paediatric patients- A double bllind randomised control trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031633
Enrollment
60
Registered
2021-03-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: K400- Bilateral inguinal hernia, with obstruction, without gangrene Health Condition 2: K612- Anorectal abscess Health Condition 3: K624- Stenosis of anus and rectum Health Condition 4: K628- Other specified diseases of anus and rectum Health Condition 5: K638- Other specified diseases of intestine Health Condition 6: K623- Rectal prolapse Health Condition 7: K409- Unilateral inguinal hernia, without obstruction or gangrene Health Condition 8: N219- Calculus of lower urinary

Interventions

Intervention1: Caudal block will be performed after induction and before the start of surgery, using standard techniques.: Patients will receive 0.25% bupivacaine + 1mcg/kg dexmedetomidine Control Int

Sponsors

Mohammad Faseehullah Alam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patient aged 1years to 5 years who are undergoing lower abdominal and perineal surgery. 2) ASA 1 and ASA 2 . 3) Consenting patients.

Exclusion criteria

Exclusion criteria: 1) Infection at the site of injection. 2) No previous abdominal surgery. 3) Patients with sepsis. 4) Patients with coagulopathy. 5) Patients refusal.

Design outcomes

Primary

MeasureTime frame
To compare post operative FLACC score every 2 hours for the next 24 hours between both groups.Timepoint: Every 2 hours for next 24 hours .

Secondary

MeasureTime frame
1)To compare postoperative paracetamol need as rescue analgesia. 2)To compare hemodynamic between both groups. Timepoint: 24 hours

Countries

India

Contacts

Public ContactMohammad Faseehullah Alam

IGIMS

faseehullah.alam@yahoo.com9155366231

Outcome results

None listed

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