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CTRI Number  CTRI/2024/03/063544 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 03/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effectiveness of Ketamine-Dexmedetomidine vs. ketamine-midazolam combination for providing sedation and analgesia in children undergoing infraumbilical surgeries under caudal anesthesia.  
Scientific Title of Study   Ketamine-Dexmedetomidine Vs Ketamine-Midazolam combination for peri-operative Sedo-analgesia in preschool children undergoing infraumbilical surgeries under caudal anaesthesia - A comparative randomized study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himanshu Dhawan 
Designation  PG 3rd year anesthesia resident 
Affiliation  Sardar Patel Medical College Bikaner 
Address  Department of Anaesthesia, sp medical college PBM Hospital Bikaner, Rajasthan

Bikaner
RAJASTHAN
334001
India 
Phone  09461059340  
Fax    
Email  drhimanshudhawan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kanta Bhati 
Designation  Senior Professor 
Affiliation  Sardar Patel Medical College Bikaner 
Address  Department of anaesthesia sp medical college and A.G of hospitals

Bikaner
RAJASTHAN
Bikaner
India 
Phone  09413466688  
Fax    
Email  drkantabhati67@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kanta Bhati 
Designation  Senior Professor 
Affiliation  Sardar Patel Medical College Bikaner 
Address  department of anaesthetics sp medical college and A.G. of hospitals

Bikaner
RAJASTHAN
Bikaner
India 
Phone  09413466688  
Fax    
Email  drkantabhati67@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Medical College, SP medical college Road, PBM Hospital , Sardar Patel colony, Bikaner, Rajasthan 334001 
 
Primary Sponsor  
Name  Sardar Patel Medical College Bikaner Rahasthan 
Address  Department of Anesthesiology Sardar Patel medical college Bikaner 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Himanshu Dhawan  Sardar Patel Medical College  Department of anesthesiology OT -A block PBM hospital,Sardar Patel medical college Bikaner
Bikaner
RAJASTHAN 
09461059340

drhimanshudhawan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical and Research Board, Sardar Patel Medical College,bikaner   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K37||Unspecified appendicitis, (3) ICD-10 Condition: Q531||Undescended testicle, unilateral,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caudal Anaesthesia under sedo-Analgesia  Under all aseptic precautions a sterile blunt 22-gauge needle was introduced in the caudal space by identifying sacral hiatus in between two sacral cornu. after confirming caudal epidural space by negative aspiration of blood and CSF, 0.25% bupivacaine (1 ml/kg) was injected slowly over 60s. Then, the patient was turned to supine position and level of sedation was assessed using RASS.  
Comparator Agent  Sedo-Analgesic Efficacy of Intravenous Ketamine-Dexmedetomidine and Ketamine-Midazolam Combination  Intravenous bolus dose of inj.Dexmedetomidine 1mcg/kg or inj. Midazolam 0.05mg/kg was given followed by infusion of either inj. Dexmedetomidine 0.7mcg/kg/hr or Inj. Midazolam 0.1mg/kg/hr via infusion pump as per the allocated group. The Richmond Agitation Sedation Score (RASS) was used to check the level of sedation. When the RASS score was ≤ 2 the child was put in lateral position and inj. ketamine 2mg/kg was given and patient was oxygenated with facemask/nasal prongs at the rate 4-6 L/min. Under all aseptic precautions a sterile blunt 22-gauge needle was introduced in the caudal space by identifying sacral hiatus in between two sacral cornu. The needle was inserted at a 60-degree angle and the needle was advanced until a “pop” was felt. The needle was then lowered to a 20-degree angle and advanced an additional 2-3 mm to make sure the bevel was in the caudal epidural space, after confirming caudal epidural space by negative aspiration of blood and CSF, 0.25% bupivacaine (1 ml/kg) was injected slowly over 60s. Then, the patient was turned to supine position and level of sedation was assessed using RASS. Additional sedative doses of inj. Ketamine 1mg/kg was given as required intraoperatively. Surgery will be allowed after 15 -20 mins of caudal block.Near the end of surgery the infusion pump delivering the allocated drug will be stopped and the level of sedation will be recorded using RASS before shifting to PACU when RASS more than -2. After surgery patient will be shifted to PACU with stable hemodynamics and oxygen saturation 95% on room air. Sedation score will be assessed in PACU at 30 min and then at 1h, 2h,3h & so on using Steward Recovery Score. Surgeon and parent’s satisfaction and adverse events will be recorded. We will conclude our study when the steward recovery score will be more than or equal to 6.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. ASA Grade I to III
2. Infraumbilical elective surgeries
 
 
ExclusionCriteria 
Details  1. Patient’s parents or caretaker’s refusal.
2. Allergy to the drugs used in the study.
3. Pre-existing neuromuscular disorder or spinal deformities.
4. Raised ICT (Intra Cranial Tension).
5. Coagulation defect.
6. Local site infection.
7. Severe hypovolemia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Compare the Perioperative Sedo-Analgesic Efficacy of Intravenous Ketamine-Dexmedetomidine and Ketamine-Midazolam Combination in Paediatric Patients Posted for Infraumbilical Surgeries Under Caudal Epidural Block to-
1. observe limb movement at time of needle prick for caudal block.
2. observe onset time and level of sedation.
3. observe intraoperative hemodynamic parameters.

 
till end of the surgery.

 
 
Secondary Outcome  
Outcome  TimePoints 
1) To observe quality and duration of postoperative sedation.
2) Surgeon satisfaction.
3) To observe any complications and side effects.
 
till the drug effect is over. 
 
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 4 
Date of First Enrollment (India)   15/03/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

Unlike adults, children are more anxious and uncooperative during invasive and painful clinical procedures. Sedation and analgesia are required to keep the child immobile to facilitate painful procedures.

Various Sedo-analgesic drugs such as ketamine, dexmedetomidine, midazolam, and propofol either alone or in combination are commonly used for several painful invasive procedures with variable degrees of success.

Caudal epidural analgesia is one of the most popular and commonly performed regional blocks in pediatric anesthesia.

Caudal blocks combined with periprocedural sedation are an efficient way to offer perioperative analgesia for painful infraumbilical interventions. 

They enable not only early ambulation but also perioperative hemodynamic stability and spontaneous breathing in children with cardiopulmonary co-morbidities.

Bupivacaine has been in clinical use for more than 30 yr and is widely used for caudal epidural analgesia in children because of its long duration of action and beneficial ratio of sensory to motor block.

The combination of Dexmedetomidine-Ketamine (DexKet) and Midazolam-Ketamine (MiKe) seems to have favorable characteristics in the pediatric population.

Ketamine is an anesthetic and analgesic agent with a wide range of applications in paediatric anesthesia. Ketamine (KET) is a phencyclidine derivative whose action is due to the central dissociation of the cortex from the limbic system providing both sedative and analgesic properties while preserving upper airway muscular tone and respiratory drive. It has a rapid onset with a short duration of action that induces good analgesia, sedation, and amnesia with a rapid recovery. ketamine‑induced agitation can be overcome by co‑administration of other drugs. Numerous studies have been tried to compare different drugs such as midazolam, dexmedetomidine (Dex), propofol, clonidine, and haloperidol to reduce these adverse responses.

Dexmedetomidine (DEX) is a specific central alpha 2-adrenergic agonist that is associated with sedative and analgesic sparing effects, reduced delirium and agitation, perioperative sympatholytic, cardiovascular stabilizing effect and preservation of respiratory function.

When used together, DEX may prevent tachycardia, hypertension, salivation and emergence phenomena from KET, whereas KET may prevent bradycardia and hypotension which has been reported with DEX. An additional benefit of rapid onset of sedation.

Midazolam is a benzodiazepine used for procedural sedation, and to treat severe agitation. Midazolam induces sleepiness, decreases anxiety, and causes amnesia.It has a fast onset time for sedative effects and a fast recovery period.

The combination of midazolam and ketamine provides effective procedural sedation and analgesia and appears to be safe in pediatric patients.

Therefore, we planned to compare the efficacy of the Dexmedetomidine-Ketamine and Midazolam- Ketamine combination for sedo-analgesia in pediatric patients undergoing infraumbilical surgeries under caudal epidural block.


 
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