Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children

NCT ID: NCT05194904

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-11-30

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

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

group 1

ketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

This is a prospective randomised clinical study designed to assess the effect of intravenous ketorolac versus intravenous dexmedetomidin on postoperative pain after hypospadias repair in children

group 2

Dexmedetomidine group: number : 30 patients, time : after intubation, dose 1 μg/kg

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

This is a prospective randomised clinical study designed to assess the effect of intravenous ketorolac versus intravenous dexmedetomidin on postoperative pain after hypospadias repair in children

Interventions

Dexmedetomidine

This is a prospective randomised clinical study designed to assess the effect of intravenous ketorolac versus intravenous dexmedetomidin on postoperative pain after hypospadias repair in children

Intervention Type: DRUG

Other Intervention Names

ketorolac

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Muhammed Samir Ghitany

resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Muhammed Samir Ghitany, master

Role: CONTACT

muhammadsamir248@gmail.com

+201096594245

Khaled Abdel-Baki Abdel-Rahman, prof

Role: CONTACT

khaledbaky@aun.edu.eg

+201008182061

References

Gao J, Sun Z, Xiao Z, Du Q, Niu X, Wang G, Chang YW, Sun Y, Sun W, Lin A, Bresnahan JC, Maze M, Beattie MS, Pan JZ. Dexmedetomidine modulates neuroinflammation and improves outcome via alpha2-adrenergic receptor signaling after rat spinal cord injury. Br J Anaesth. 2019 Dec;123(6):827-838. doi: 10.1016/j.bja.2019.08.026. Epub 2019 Oct 14.

Reference Type: BACKGROUND

PMID: 31623841 (View on PubMed)

Blaise G, Roy WL. Postoperative pain relief after hypospadias repair in pediatric patients: regional analgesia versus systemic analgesics. Anesthesiology. 1986 Jul;65(1):84-6. doi: 10.1097/00000542-198607000-00016. No abstract available.

Reference Type: RESULT

PMID: 3729064 (View on PubMed)

Other Identifiers

intravenous dexmedetomidin

Identifier Type: -

Identifier Source: org_study_id