Postoperative Pain
Conditions
Brief summary
this study will be undertaken to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.
Detailed description
Oro-facial clefts are the most prevalent craniofacial birth defects and the second most common birth anomaly, second only to clubfoot \[Strong & Buckmiller 2001\]. Cleft lip surgery is associated with appreciable postoperative pain in children Alleviation of postoperative pain is important in these patients. The fear of respiratory depression using opioids has renewed the interest in regional anesthesia to provide safe and effective postoperative analgesia. Infra-orbital nerve block has been advocated as a suitable local analgesic technique for cleft lip surgery and superficial surgery on the mid face \[Morton 2004, Takmaz et al. 2009, Rajesh et al. 2011, Jindal et al. 2011\].The infra-orbital nerve supplies the upper lip, lower eyelid, and adjacent skin of the cheek and nose. Unilateral or bilateral infra-orbital nerve block has been performed with a very high success rate. The investigators designed this study to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.
Interventions
DRUGBupivacaine
Infraorbital nerve block using bupivacaine 0.25% on each side.
DRUGKetamine
Infraorbital nerve block using 0.5mg/kg ketamine on each side.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
(ASA) physical status I and II aged less than 2 years undergoing elective cleft lip repair (with or without cleft palate) under general anesthesia.
Exclusion criteria
Patients with local infection at the site of injection of block, history suggestive of drug allergy, any systemic disease that compromises the cardiovascular, respiratory or neurological function, other congenital anomaly, history of upper or lower airway disease, coagulation disorders, and children with history of sleep apnea and in whom postoperative ventilation may be required will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative analgesic consumption | 24 hours postoperative | the total consumption of analgesics in the first 24h postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative The Face, Legs, Activity, Cry, Consolability ( FLACC) pain score | 24 h postoperative. | FLACC pain score will be recorded on arrival to the recovery room (0) and at 1, 2, 3, 4, 8, 12, and 24 hours postoperative. |
| Parent satisfaction score | 24 h postoperative | The parents will be asked to evaluate their satisfaction regarding pain control at the end of 24 hours over a score of 4 points (1=bad, 2=moderate, 3=good, 4=excellent). |
Countries
Egypt
Outcome results
None listed