| CTRI Number |
CTRI/2025/12/098552 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Low and Standard Doses of Morphine in Young Children to See Which Causes Fewer Side Effects After Surgery |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKANKSHA JENA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE, PUNE |
| Address |
Department of anaesthesiology
Armed Forces Medical College Wanowrie
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
09769647949 |
| Fax |
|
| Email |
akankshajena.work@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sangeeta Khanna |
| Designation |
Professor |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE, PUNE |
| Address |
Department of anaesthesiology
Armed Forces Medical College Wanowrie
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8004912390 |
| Fax |
|
| Email |
sangeetakhanna1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajit Kumar |
| Designation |
Associate Professor |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE, PUNE |
| Address |
Department of anaesthesiology
Armed Forces Medical College Wanowrie
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9051068139 |
| Fax |
|
| Email |
rajit.pandey@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AKANKSHA JENA |
| Address |
ARMED FORCES MEDICAL COLLEGE PUNE |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| drrajitkumar |
Armed Forces Medical College |
Department of Anaesthesiology and critical care
Wanowrie
Pune
Pune
MAHARASHTRA |
9051068139
rajit.pandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECAFMCPUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hernia ICD K40-K46
circumcision Z41.2
VUR ICD10 PCS OTBNOZZ
appendectomy K35.2
K40.90 ICD-10 code for herniotomy
orchidopexy ICD 10 PCS OVSCOZZ |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group M15 Morphine 15 µg 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 2hourly for 24 hours. |
| Comparator Agent |
Group M30
Morphine 30 µg per kg plus 0.2percent ropivacaine (1 ml per kg) in caudal block |
To assess occurrence of post operative nausea vomiting and post operative urinary retention 2hourly for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I & II patients undergoing infraumbilical surgery |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the common incidence of side effects, including post operative nausea vomiting (PONV) and urinary retention between the two dosing groups |
post op 2hourly assessment will be done for 24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
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. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative pain is a major concern in pediatric patients undergoing infraumbilical surgeries such as herniotomy, orchidopexy, and circumcision. Inadequately managed pain in children can lead to physiological stress responses, delayed recovery, and long term behavioral disturbances. Although infraumbilical surgeries are usually short in duration, effective control of postoperative pain is essential to promote early ambulation, reduce the length of hospital stay, and improve overall patient comfort. Several analgesic strategies are used in this age group, including systemic medications such as non steroidal anti inflammatory drugs and opioids, as well as regional anesthesia techniques. Among the regional approaches, the caudal block is one of the most commonly performed procedures in pediatric anesthesia. It provides reliable intraoperative and postoperative analgesia for surgeries below the umbilicus, has a high success rate, and offers a favorable safety profile. To prolong the duration of analgesia from caudal blocks, various adjuvants have been added to local anesthetics. Morphine, a hydrophilic opioid, is one of the most widely used adjuvants in caudal anesthesia. Doses typically range from 10 to 30 micrograms per kilogram and have been shown to extend postoperative pain relief for 12 to 24 hours. However, higher doses of caudal morphine are known to increase the risk of adverse effects including postoperative nausea and vomiting, pruritus, urinary retention, and in rare cases respiratory depression. Recent investigations comparing lower and standard doses have suggested that reducing the dose may maintain analgesic efficacy while minimizing these unwanted effects. Considering the narrow therapeutic range of caudal morphine in young children, the present study is designed to compare the incidence of postoperative nausea, vomiting, and urinary retention between two doses, 15 micrograms per kilogram and 30 micrograms per kilogram, in children aged one to six years undergoing infraumbilical surgeries. This comparison will help determine whether a lower dose can provide effective analgesia with fewer complications. |