Comparative Efficacy & Safety of Dexmedetomidine vs Tramadol in Paeds Hernioraphy. A Caudal Anaesthesia Approach

NCT06735443 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2094/SLMC/SWL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Among the postoperative adverse effects, pain has significant importance. Caudal block is a common technique for pediatric analgesia for infraumbilical surgeries. Because of the shortduration of analgesia with bupivacaine alone various additive have been used to prolong the action of bupivacaine. Tramadol has a centrally acting analgesic effect via opioid receptors.Adding Dexmedetomidine to bupivacaine has proven effectiveness for postoperative painrelief. But not much research has been conducted before regarding this comparison which can help us to find the more effective drug for induction of anesthesia.So we want to conduct this randomized trial. Sample size of 60 cases; 30 cases in each group will be included through Nonprobability convenience sampling and will be randomly divided in two groups. In group A,patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine0.5 μg/kg. In group B, patients will be given 0.25% bupivacaine 1 mL/kg with 1mg/kg of tramadol. Heart rate and mean arterial pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 mins of induction and at the time of extubation. After surgery, total duration from surgery and first rescue analgesia will be noted. All the information will be recorded on proforma. Data will be entered \& analyzed by using SPSS version 20. Both groups will be compared for mean heart rate, MAP and time to first rescue analgesia by using independent samples t-test. P-value ≤0.05 will be considered as significant. So this study will be done in a local setting to get local evidence and implement the use of more appropriate drug with less postop complications, especially in pediatric age group patients. This will help to improve our practice and local guidelines.

Conditions

Hemodynamic Stability; Post Operative Pain; Inguinal Hernia Repair

Outcome Measures

Primary Outcomes (3)

• Hemodynamic Stability

  heart rate

  Heart rate will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes of induction and at the time of extubation.

• Post Op Analgesia

  post operative first rescue analgesia

  After 24hours, children will be assessed for postoperative pain score

• Hemodynamic Stability

  Blood pressure

  Blood pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes of induction and at the time of extubation.

Study Arms (2)

Bupivacaine with Dexmetedomidine group

EXPERIMENTAL

In group A, patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine 0.5μg/kg

Drug: Bupivacaine with Dexmetedomidine

Bupivacaine with Tramadol group

EXPERIMENTAL

In group B, patients will be given 0.25% bupivacaine 1 mL/kg with 1 mg/kg of tramadol

Drug: Bupivacaine with Tramadol

Interventions

Bupivacaine with Dexmetedomidine DRUG

children will be anesthetized generally using Propofol 2.5mg/kg bodyweight, Atracurium 0.5mg/kg body weight and appropriately sized endotracheal tube (ETT) according to the age. Patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine 0.5μg/kg. Neostigmine 0.05mg/kg plus Glycopyrrolate 0.2mg/1mg of neostigmine will be used as reversal agents. After surgery, children will be shifted in post-surgical wards and will be followed-up there for 24 hours. After 24hours, children will be assessed for postoperative pain score.

Also known as: Bupicain with Dex

Bupivacaine with Dexmetedomidine group

Bupivacaine with Tramadol DRUG

children will be anesthetized generally using Propofol 2.5mg/kg bodyweight, Atracurium 0.5mg/kg body weight and appropriately sized endotracheal tube (ETT) according to the age. Patients will be given 0.25% bupivacaine 1 mL/kg with 1 mg/kg of tramadol. Neostigmine 0.05mg/kg plus Glycopyrrolate 0.2mg/1mg of neostigmine will be used as reversal agents. After surgery, children will be shifted in post-surgical wards and will be followed-up there for 24 hours. After 24hours, children will be assessed for postoperative pain score.

Also known as: Bupicain with Tramal

Bupivacaine with Tramadol group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children of age 5-15 years.
• Either gender,
• Elective inguinal hernia surgery.
• ASA I-II
• Proposed duration of surgery \<60 minutes.

You may not qualify if:

• Emergency surgery
• Children with evidence of infection at back, allergy to trial drugs, bleeding/coagulation disorder (PT\>15sec), history of developmental delay, sepsis, pre-existing neurological or spinal diseases (on medical record)
• Expected duration of surgery \>120 minutes

Sponsors & Collaborators

• Sahiwal medical college sahiwal: lead
• Department of medical education: collaborator

Study Sites (1)

Sahiwal Medical College Sahiwal

Sahiwal, Punjab Province, 57000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Tramadol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• Adeel Riaz, MD

  Sahiwal Teaching Hospital, Sahiwal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Anaesthetist

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 16, 2024
• Study Start: March 6, 2021
• Primary Completion: April 11, 2022
• Study Completion: May 10, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

PA (1)