Dexmedetomidine added to bupivacaine caudal block for children having open appendectomy.
The Effectiveness of Dexmedetomidine as an Adjuvant for Bupivacaine Caudal Block in Pediatric Open Appendectomy Under General Anesthesia
This trial will test whether adding dexmedetomidine to bupivacaine in a caudal block gives children longer and better pain relief and fewer emergence problems after open appendectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 7 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07088900 on ClinicalTrials.gov |
What this trial studies
Children (ASA I–II) undergoing open appendectomy under general anesthesia at Ain Shams University will receive a caudal block with either bupivacaine alone or bupivacaine plus dexmedetomidine. Investigators will record pain scores, duration of postoperative analgesia, time to first analgesic request, opioid consumption, incidence of emergence delirium, and any adverse events. Recovery quality measures and safety monitoring will be compared between the two groups. Standard anesthetic care will be maintained for all participants.
Who should consider this trial
Good fit: Children scheduled for open appendectomy under general anesthesia who are ASA physical status I–II and whose legal guardians can provide written informed consent are appropriate candidates.
Not a fit: Children with known allergy to local anesthetics or dexmedetomidine, coagulation disorders, active infection at the injection site, significant lumbosacral spine abnormalities, pre-existing neurological or psychiatric disorders, severe asthma, or anticipated surgery longer than 2.5 hours would not be expected to benefit and are excluded.
Why it matters
Potential benefit: If successful, the combination could provide longer-lasting pain relief after surgery, reduce opioid use, and lead to smoother recoveries for children.
How similar studies have performed: Similar pediatric trials of dexmedetomidine added to caudal bupivacaine have often shown improved postoperative analgesia and reduced emergence agitation, though dosing and safety data vary.
Eligibility criteria
Show full inclusion / exclusion criteria
inclusion criteria: * ASA (American Society of Anesthesiologists) physical status I or II. * Legal guardian provides written informed consent. Exclusion Criteria * Refusal of participation by the legal guardian. * Known allergy or hypersensitivity to local anesthetics or dexmedetomidine. * Coagulation disorder or receiving anticoagulant therapy. * Active infection at or near the injection site. * Significant anatomical abnormalities of the lumbosacral spine. * Pre-existing neurological disorders, psychiatric disorders, or a history of convulsions. * Anticipated surgery time of more than 2.5 hours. * Patients with severe asthma or active wheezing.
Where this trial is running
Cairo
- Ain Shams university hospitals — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.