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)?
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/06/054396
- Lead Sponsor
- Lady Hardinge Mecical College and associated Hospitals
- Brief Summary
The study will be conducted only after approval from the Institutional Ethics Committee and will be registered with Clinical Trials Registry India (CTRI). Patients fulfilling the inclusion criteria will be recruited for the study. A detailed pre-anaesthetic check-up and investigations will be done for all patients. The spine will be examined for any evidence of vertebral column anomalies, skin infection, bony landmarks and previous operations. A verbal assent from the subject and written informed voluntary parental consent will be obtained for anaesthesia, surgery and participation in the study. A senior experienced pediatric anaesthesiologist will perform all the epidural blocks. Observation and data collection will be done by an independent observer.
**Randomization:** Patients will be randomized to one of the two groups in the operating room prior to giving anaesthesia using random numbers generated through an online randomization service.The unique randomization code will be allocated to each patient and used to randomize consenting patients equally with no restrictions or bias to either of the two study groups.
**Group LF** – (0.125% levobupivacaine + 1 μg/mL fentanyl) @ 0.3 mL/Kg/hr
**Group LC –**(0.125% levobupivacaine + 1 μg/mL clonidine) @ 0.3 mL/Kg/hr
**Allocation concealment:** The results of the allocation will be concealed in sequentially numbered sealed opaque envelopes mentioning the code and the group number. These envelopes with results of allocation will not be seen by the research coordinator prior to sealing and will only be kept by the coordinator after sealing. On the day of surgery, the coordinator will hand over an envelope to the senior anaesthesiologist supervising the OT.
Patients will be kept nil per oral (for solid food 8 hours, semisolid food 6 hours, breastmilk 4 hours, clear liquids 2 hours) prior to surgery as per standard guidelines. The children will be pre-medicated with oral midazolam (0.5 mg/Kg) 30 min before the surgical procedure. After arrival in the operating room, a 22G/24G peripheral intravenous catheter will be inserted. Standard monitoring will be applied, including non-invasive blood pressure (NIBP), electrocardiograph (ECG) with heart rate (HR), pulse oximetry (SpO2) and temperature.
Patients will be pre-oxygenated with 100% oxygen for 3 minutes and anaesthesia will be induced intravenously with slow administration of injection fentanyl 2µg/Kg and injection propofol 2mg/Kg. After confirming adequate mask ventilation, injection rocuronium 0.6 mg/Kg will be administered intravenously for neuromuscular blockade. The trachea will be intubated under direct vision with an appropriately sized micro-cuff endotracheal tube. Anaesthesia will be maintained with oxygen in nitrous oxide (N2O) and sevoflurane, maintaining a minimum alveolar concentration (MAC) of 1.0–1.2, with the patient on controlled mechanical ventilation. Electrocardiograph with HR, NIBP, SpO2, end tidal carbon dioxide (EtCO2), end tidal anaesthetic gas concentration, MAC and temperature will be monitored for all patients throughout.
After induction of general anaesthesia, the child will be placed in lateral decubitus position. Under all aseptic precautions, using a loss-of-resistance technique, a touhyneedle (B Braun Perifx® ONE 18 G) will be used to enter the epidural space in the midline at the appropriate intervertebral space. The epidural catheter will be advanced for 3–4 cm into the epidural space. A bolus of 0.25% levobupivacaine of 0.3 mL/Kg will be administered through the epidural catheter after a negative aspiration for blood and cerebrospinal fluid. This will be repeated at one hourly interval as per the requirement of the case. The patient would then be handed over for surgery. At the end of surgery an epidural bolus of 0.3 mL/Kg of the drug to be given in infusion will be administered, following which the epidural infusion (LA with adjuvants) will be started for the postoperative pain relief. Patients in Group LF will be given 0.125% levobupivacaine + 1μg/mL fentanyl @ 0.3mL/Kg/hr. Patients in Group LC will receive 0.125% levobupivacaine + 1μg/mL clonidine @ 0.3mL/Kg/hr. Thereafter, anaesthesia will be terminated, neuromuscular blockade will be reversed and the patient’s trachea will be extubated. The patients will be initially monitored in the post anaesthesia care unit (PACU) and subsequently shifted to the pediatric surgery ward
Pain will be assessed usingCHEOPS score postoperatively at 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours. If the pain score is > 6, injection paracetamol in a dose of 15mg/Kgintravenously (maximum of four doses in 24 hours) will be given as the rescue analgesic and noted. Diclofenac sodium in a dose of 0.1 mg/Kg IV will be given if there is no reduction in pain score after 30 minutes of administration of intravenous paracetamol, and noted. Sedation as per University of Michigan Sedation Scale (UMSS) will be assessed at 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively. Any drug adverse effects (nausea and vomiting, pruritus, hypotension, bradycardia, respiratory depression, sedation, dry mouth, urinary retention) will also be recorded. Patients who experience vomiting will receive intravenous ondansetron 0.1mg/kg. Pruritus will be managed with intravenous 10mg propofol. Episode of hypotension, defined as fall in systolic blood pressure of greater than 20% from the baseline, will be treated with IV bolus of normal saline (10- 20mL/Kg in divided doses). Bradycardia, defined as fall in heart rate of greater than 20% from the baseline, will be treated with injection atropine 0.01 mg/kg administered intravenously. Respiratory depression, defined as fall in oxygen saturation (SpO2) < 94% will be treated by propped up position and oxygenation via simple face mask or venture-mask. Serious adverse effects such as local anaesthetic systemic toxicity (LAST), paraesthesia, and prolonged motor block will be noted, managed and reported to the IEC within 24 hours. Parental satisfaction will be assessed using five point satisfaction scale (Likert Satisfaction Scale) at 48 hours postoperatively. Time of first analgesic request (injection diclofenac sodium 0.1mg/Kg) after the removal of epidural catheter after 48 hours of surgery will also be recorded. All observations will be recorded by an independent observer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Children belonging to age group 1-7 years, scheduled for laparotomy under general anaesthesia, requiring an epidural catheter for postoperative analgesia.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 laparotomy Postoperative period of 48 hrs
- Secondary Outcome Measures
Name Time Method Median (IQR) University of Michigan Sedation Score (UMSS) 30 minute, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours & 48 hours postoperatively Median [interquartile range (IQR)] CHEOPS score 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) 30 minute, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours & 48 hours postoperatively Median (IQR) parental satisfaction score (Likert Satisfaction Scale) 48 hours postoperatively Mean (±SD) time in hours, of first analgesic request after the removal of epidural catheter after 48 hours of surgery Time(in hour) of first analgesic request after the removal of epidural catheter after 48 hours of surgery
Trial Locations
- Locations (1)
Lady Hardinge Mecical College and associated Hospitals
🇮🇳Central, DELHI, India
Lady Hardinge Mecical College and associated Hospitals🇮🇳Central, DELHI, IndiaDr Nimish AgarwalPrincipal investigator8130586796nim98agarwal@gmail.com