To compare which one,out of dexamethasone and clonidine provides better pain relief when added as an additive in transversus abdominis plane block

A randomised controlled trial to compare the efficacy of clonidine versus dexamethasone as an adjunct in ultrasound guided transversus abdominis plane block in children undergoing laparotomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049738

Enrollment

Registered

2023-02-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system

Interventions

Intervention1: Ultrasound Guided Transversus Abdominis Plane Block: To compare the efficacy of clonidine versus dexamethasone as an adjunct in ultrasound guided transversus abdominis plane block in ch

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex, belonging to age group 1-8 years, scheduled for laparotomy

Exclusion criteria

Exclusion criteria: 1. History of any relevant drug allergy or chronic pain 2. Coagulation disorder 3. Infection at the needle insertion site 4. Duration of surgery > 3 hours

Design outcomes

Primary

Measure	Time frame
Mean duration of postoperative analgesia (in hours) in children receiving clonidine or dexamethasone as an adjunct in TAP block for laparotomy Timepoint: at the end of study	—

Secondary

Measure	Time frame
1. Mean (Â±SD) requirement of analgesics (Î¼g) in 24 hours postoperatively 2. Median [ Interquartile range (IQR)] CHEOPS at 30 minute, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively 3. Proportion of patients developing side effects of the drugs - clonidine or dexamethasone (dry mouth, hypotension, bradycardia) 4. Median (IQR) University of Michigan Sedation Score (UMSS) at 30 minutes, 3 hours, 6 hours, 12 hours and 24 hours interval. 5.Median (IQR) parental satisfaction score (Likert scale) at 24 hours postoperatively Timepoint: 1.24 hours postoperatively 2.30 minute, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively 4. 30 minute, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively 5.24 hours postoperatively	—

Measure

Time frame

1. Mean (Â±SD) requirement of analgesics (Î¼g) in 24 hours postoperatively 2. Median [ Interquartile range (IQR)] CHEOPS at 30 minute, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively 3. Proportion of patients developing side effects of the drugs - clonidine or dexamethasone (dry mouth, hypotension, bradycardia) 4. Median (IQR) University of Michigan Sedation Score (UMSS) at 30 minutes, 3 hours, 6 hours, 12 hours and 24 hours interval. 5.Median (IQR) parental satisfaction score (Likert scale) at 24 hours postoperatively Timepoint: 1.24 hours postoperatively 2.30 minute, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively 4. 30 minute, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively 5.24 hours postoperatively

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Countries

India

Contacts

Public ContactJyotsana Arora

Lady Hardinge Medical College

ranjusingh1503@yahoo.com9811151285

Outcome results

None listed

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