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NCT Number: NCT06735443

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

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.

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Key information

Conditions

Hemodynamic Stability Inguinal Hernia Repair Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sahiwal Medical College Sahiwal

Sahiwal, Punjab Province, 57000, Pakistan

About this study

After taking approval from hospital ethical committee, 60 children fulfilling the selection criteria will be included in the study from ward of Department of Pediatrics, DHQ Teaching Hospital, Sahiwal. An informed consent will be taken. Demographic information (name, age,gender, weight, ASA and duration of surgery) will be noted.Then children will be randomly divided in two groups by using lottery method for caudal block. In both groups children will be anesthetized generally using Propofol 2.5mg/kg bodyweight, Atracurium 0.5mg/kg body with dexmedetomidine 0.5μg/kg. In group B, patients will be given0.25% bupivacaine 1 mL/kg with 1mg/kg of tramadol. All anesthesia procedures will be done by researcher under supervision of senior consultant anesthesiologist having 4 years residency experience. Heart rate and mean arterial pressure will be assessed after 5,10,15 and 30 mins of induction and at the time of extubation.Neostigmine 0.05mg/kg plus Glycopyrolate 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. Children will be assessed for postoperative pain score. If pain score will be greater than or equal to 5 on FLACC scale, then rescue analgesia will be given and total duration from surgery and first rescue analgesia will be noted (as per operational definition). All the information will be recorded on proforma attached.

definition). All the information will be recorded on proforma (attached). pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes weight and appropriate sized endotracheal tube (ETT) according to the age. In group A, patients will be given 0.25% bupivacaine 1 mL/kg

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • • 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

Treatment and study plan

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.

Other names: Bupicain with Dex

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.

Other names: Bupicain with Tramal

Primary outcomes

  1. Hemodynamic Stability

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

    heart rate

  2. Post Op Analgesia

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

    post operative first rescue analgesia

  3. Hemodynamic Stability

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

    Blood pressure

Sponsors and collaborators

Lead sponsor

Sahiwal medical college sahiwal

Other Gov

Collaborators

  • Department of medical education

Registry information

Official study title

Comparison Of Dexmedetomidine Versus Tramadol As An Adjuvant With Bupivacaine In Caudal Block For Intra-Operative Hemodynamic Stability And Post-Operative Pain In Children Undergoing Inguinal Hernia Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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