Infra-orbital Nerve Block for Post Operative Analgesia in Children Undergoing Cleft Lip Surgery.

Assiut University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Pain

Interventions

BupivacaineDRUG

Infraorbital nerve block using bupivacaine 0.25% on each side.

KetamineDRUG

Infraorbital nerve block using 0.5mg/kg ketamine on each side.

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Assiut university hospitals

Asyut, Assiut Governorate, Egypt

Outcomes

Primary Outcomes

postoperative analgesic consumption

the total consumption of analgesics in the first 24h postoperative

Time frame: 24 hours postoperative

Secondary Outcomes

Postoperative The Face, Legs, Activity, Cry, Consolability ( FLACC) pain score

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.

Time frame: 24 h postoperative.

Parent satisfaction score

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).

Time frame: 24 h postoperative

Data from ClinicalTrials.gov

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