Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children

Phase 2

• Conditions: Postoperative Pain
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT05194904
• Lead Sponsor: Assiut University

Brief Summary

This study aimed to evaluate the efficacy of intravenous ketorolac versus dexmedetomidine as analgesia after Hypospadias repair surgery to determine the optimal procedure for pain control and postoperative reduction of analgesic use

Detailed Description

The guidelines of the American Society of Anesthesiologists (ASA) for the treatment of pain in the perioperative period define postoperative acute pain as pain present in surgical patients following the procedure.1 Almost 80% of patients undergoing surgery experience postoperative pain, and 80% of them reported moderate to severe pain intensity.2 Inadequate management of postoperative pain may lead to development of complications and prolonged recovery time with increased morbidity and mortality rates in adults.3,4 Although equivalent data for children are not available, this evidence warrants caution in pediatric population too. Appropriate treatment of postoperative pain contributes to shorter time of hospitalization, lower hospital costs, and increased level of patient satisfaction. There is enough evidence that an ineffective treatment of postoperative pain is in positive correlation with delayed wound healing, and the negative development of pain perception and chronic pain in the future.5,6 Hypospadias repair surgery is an invasive procedure whose postoperative phase is very painful.7 Pain management can be counted as an important step in all surgeries, especially in pediatric and neonatal surgical procedures. It has been reported that up to 40% of the children undergoing surgeries suffer from moderate to severe post-operative pain.8 In addition to the significance of post-operative pain management in the quality of life and satisfaction of the patients, it plays a great role in minimizing the complications and improving the surgery outcome in certain types of surgeries. In hypospadias surgery, post-operative pain results in manipulation of wounds and consequent infection, hemorrhage, and wound dehiscence.9 These complications cause significant preventable morbidities. Post-operative pain management also alleviates the local and systemic inflammation resulting in more favorable outcomes.10

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that has an analgesic efficacy similar to commonly used opioids, and that recently has found wide acceptance in the treatment of postoperative pain in a variety of surgical procedures. Ketorolac is used for moderate pain relief; it may be used to treat severe pain when associated with opioids, reducing the opioid dose. The advantage of this association is the reduction of opioid side effects such as respiratory depression, pruritus, urinary retention, sedation and nausea . 11,12,13 Dexmedetomidine is a highly selective α2-adrenergic receptor agonist commonly used in neurosurgery . The advantages of dexmedetomidine include reducing perioperative catecholamine to maintain intraoperative hemodynamic stability and exerting the unique neuroprotective effects by inhibiting the release of glutamate, pro-apoptotic proteins, and pro-inflammatory cytokines. In addition, previous studies have shown that it can reduce sedative and opioid consumption and provide better analgesic effects with lesser concern for side effects than opioids

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Study First Posted: 2022-01-18
• Last Update Posted: 2022-01-18
• Primary Completion: 2023-07
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA physical status I & II.
• Age between 2 years & 6 years old.
• Body weight below 30 Kg.

Exclusion Criteria

• Any contraindications to any drug used
• patients refusal
• recurrent surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group 1	Dexmedetomidine	ketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg
group 2	Dexmedetomidine	Dexmedetomidine group: number : 30 patients, time : after intubation, dose 1 μg/kg

Primary Outcome Measures

Name	Time	Method
Total analgesic consumption in the first 24 hours after surgery	first 24 hours	Total analgesic consumption in the first 24 hours after surgery