Caudal Dexmedetomidine vs Ketamine for Postoperative Analgesia in Pediatric DDH Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorAssiut University

About this trial

This study compares two medicines, Dexmedetomidine and Ketamine, added to caudal Bupivacaine to control pain after hip surgery in children. We will check how well each medicine reduces pain, how long the pain relief lasts, and if children need extra pain medicine. The goal is to find the safest and most effective option for postoperative pain relief in children undergoing hip surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 1 to 6 years undergoing surgery for developmental dysplasia of the hip

ASA physical status I or II

Parental or guardian informed consent obtained

Disqualifiers

Known allergy to local anesthetics, Dexmedetomidine, or Ketamine

Coagulopathy or bleeding disorders

Infection at the site of caudal injection

Neurological disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    Dexmedetomidine 1 µg/kg added to caudal Bupivacaine.

  • Ketamine

    Drug

    Ketamine 0.5 mg/kg added to caudal Bupivacaine.

  • Bupivacaine

    Drug

    Isobaric Bupivacaine 0.25% 1 ml/kg used for caudal block in both groups.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine GroupExperimental treatment 2 interventions
Group B: Ketamine GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Postoperative Pain Score (FLACC)

Pain will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability) at regular intervals (every 2-4 hours) during the first 24 hours after surgery to evaluate the effectiveness of caudal analgesia in children receiving Dexmedetomidine or Ketamine as adjuvants to Bupivacaine.

Time frame
First 24 hours post-surgery

Secondary outcomes

1

Hemodynamic Stability

Monitoring blood pressure and heart rate intraoperatively and postoperatively to assess safety of caudal adjuvants.

Time frame
Intraoperative and first 24 hours post-surgery
2

Duration of Analgesia

Time from caudal block administration to first request for rescue analgesia, measured in hours, to compare the prolongation of analgesia between Dexmedetomidine and Ketamine groups.

Time frame
From caudal block to first request for rescue analgesia
3

Adverse Effects

Recording any side effects related to caudal adjuvants, including bradycardia, hypotension, nausea, vomiting, and sedation, during the first 24 hours.

Time frame
First 24 hours post-surgery
4

Rescue Analgesia Requirement

Number of patients requiring additional analgesia within the first 24 hours post-surgery.

Time frame
First 24 hours post-surgery

Other outcomes

Sponsors and contacts

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