Is there any difference in the efficacy of two drugs (fentanyl versus clonidine) used in continuous epidural infusion (for postoperative pain relief) in children undergoing laparotomy (abdominal surgeries)?

A randomised comparison of the efficacy of fentanyl versus clonidine as an adjunct to levobupivacaine in continuous epidural infusion in children undergoing laparotomy - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054396

Enrollment

100

Registered

2023-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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: Clonidine as an adjunct to levobupivacaine in continuous epidural infusion in children, aged 1 to 7 years, undergoing laparotomy: Patients in Group LC will receive 0.125% levobupivacain

Eligibility

Inclusion criteria

Inclusion criteria: Children belonging to age group 1-7 years, scheduled for laparotomy under general anaesthesia, requiring an epidural catheter for postoperative analgesia

Exclusion criteria

Exclusion criteria: History of any relevant drug allergy or sensitivity to study drugs or chronic pain Any contraindication to neuraxial block like coagulation disorder, infection at the needle insertion site, raised intracranial pressure, obvious bony deformity

Design outcomes

Primary

Measure	Time frame
Median number of rescue analgesic doses given during postoperative period of 48 hrs in children, aged 1 to 7 years, receiving fentanyl or clonidine as an adjunct to levobupivacaine in continuous epidural infusion for laparotomyTimepoint: Postoperative period of 48 hrs	—

Secondary

Measure	Time frame
Median [interquartile range (IQR)] CHEOPS scoreTimepoint: 30 minute, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours & 48 hours postoperatively;Median (IQR) University of Michigan Sedation Score (UMSS)Timepoint: 30 minute, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours & 48 hours postoperatively;Proportion of patients developing adverse effects of the drugs (nausea & vomiting, pruritus, hypotension, bradycardia, respiratory depression, sedation, dry mouth, urinary retention)Timepoint: 30 minute, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours & 48 hours postoperatively ;Median (IQR) parental satisfaction score (Likert Satisfaction Scale)Timepoint: 48 hours postoperatively;Mean (±SD) time in hours, of first analgesic request after the removal of epidural catheter after 48 hours of surgeryTimepoint: Time(in hour) of first analgesic request after the removal of epidural catheter after 48 hours of surgery	—

Measure

Time frame

Median [interquartile range (IQR)] CHEOPS scoreTimepoint: 30 minute, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours & 48 hours postoperatively;Median (IQR) University of Michigan Sedation Score (UMSS)Timepoint: 30 minute, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours & 48 hours postoperatively;Proportion of patients developing adverse effects of the drugs (nausea & vomiting, pruritus, hypotension, bradycardia, respiratory depression, sedation, dry mouth, urinary retention)Timepoint: 30 minute, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours & 48 hours postoperatively ;Median (IQR) parental satisfaction score (Likert Satisfaction Scale)Timepoint: 48 hours postoperatively;Mean (±SD) time in hours, of first analgesic request after the removal of epidural catheter after 48 hours of surgeryTimepoint: Time(in hour) of first analgesic request after the removal of epidural catheter after 48 hours of surgery

—

Countries

India

Contacts

Public ContactDr Nimish Agarwal

Lady Hardinge Medical College and associated Hospitals

ranjusingh1503@gmail.com9811151285

Outcome results

None listed

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