Comparing Low and Standard Doses of Morphine in Young Children to See Which Causes Fewer Side Effects After Surgery

A comparative study evaluating the incidence of post operative complications with two distinct doses of morphine used as adjuvants in caudal block for paediatric patients undergoing infraumbilical surgical procedures. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098552

Enrollment

Registered

2025-12-05

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

None listed

Interventions

Intervention1: Group M15 Morphine 15 g per kg plus 0.2percent ropivacaine (1 ml per kg) caudal block: To assess occurrence of post operative nausea vomiting and post operative urinary retention 2ho

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA I & II patients undergoing infraumbilical surgery

Exclusion criteria

Exclusion criteria: 1. Known allergy or hypersensitivity to morphine, ropivacaine, or any local anaesthetic. 2. Infection at the caudal injection site or systemic infection. 3. Bleeding disorders or patients on anticoagulant 4. Chronic respiratory diseases (e.g., severe asthma, obstructive sleep apnea, or any condition predisposing to respiratory depression). 5. Congenital or acquired spinal abnormalities.

Design outcomes

Primary

Measure	Time frame
To assess the common incidence of side effects, including post operative nausea vomiting (PONV) and urinary retention between the two dosing groupsTimepoint: post op 2hourly assessment will be done for 24hours.	—

Secondary

Measure	Time frame
1.Time to first rescue analgesia, defined as the time from completion of surgery to the first requirement for additional pain medication. 2. Intraoperative and postoperative haemodynamic variation assessment. 3. Postoperative analgesia will be managed according to protocol. Pain will be assessed using the FLACC scale every two hours, with interventions implemented for scores exceeding four. 4. Sedation level will be assessed using the Ramsay Sedation Scale. Timepoint: We will continuously monitor vital parameters (heart rate, blood pressure, oxygen saturation, and respiratory rate) at baseline, preinduction, and post-induction. We will monitor vital signs every 10 minutes during the operation. Postoperatively, we will assess FLACC and Ramsay sedation scores every 15 minutes for the first two hours, then every two hours for up to 24 hours. Postoperatively, we will assess FLACC and Ramsay sedation scores every 15 minutes for the first two hours, then every two hours for up to 24 hours.	—

Measure

Time frame

1.Time to first rescue analgesia, defined as the time from completion of surgery to the first requirement for additional pain medication. 2. Intraoperative and postoperative haemodynamic variation assessment. 3. Postoperative analgesia will be managed according to protocol. Pain will be assessed using the FLACC scale every two hours, with interventions implemented for scores exceeding four. 4. Sedation level will be assessed using the Ramsay Sedation Scale. Timepoint: We will continuously monitor vital parameters (heart rate, blood pressure, oxygen saturation, and respiratory rate) at baseline, preinduction, and post-induction. We will monitor vital signs every 10 minutes during the operation. Postoperatively, we will assess FLACC and Ramsay sedation scores every 15 minutes for the first two hours, then every two hours for up to 24 hours. Postoperatively, we will assess FLACC and Ramsay sedation scores every 15 minutes for the first two hours, then every two hours for up to 24 hours.

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Countries

India

Contacts

Public ContactRajit Kumar

ARMED FORCES MEDICAL COLLEGE, PUNE

sangeetakhanna1996@gmail.com8004912390

Outcome results