A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation

Study Overview
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Brief Summary
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The hypothesis of this study is to investigate and compare the efficacy between the administrations of single intravenous (IV) dose of dexmedetomidine versus nalbuphine in preventing immediate postoperative agitation in children undergoing cleft palate repair.

Detailed Description
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A written informed consent will be taken from the guardian of children.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled study drug and 90 patients will be allocated in three groups (of 30 patients each) to receive the study drug at the end of surgery; a single dose of 0.5 µ/kg IV dexmedetomidine (Group D) or a single dose of 0.1 mg/kg IV nalbuphine (Group N) or same volume of saline placebo (Group C).

Official Title
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Optic Nerve Sheath Diameter (ONSD): A New Modality to Assess Postoperative Agitation After a Single Bolus of Dexmedetomidine Versus Nalbuphine in Children With Cleft Palate Repair

Conditions
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Cleft Palate

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Nalbuphine
* Other: 0.9% saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II Elective cleft palate repair ± cleft lip surgery under general anesthesia. Exclusion Criteria: Ventriculo-peritoneal shunt Suspected meningitis Congenital hydrocephalus Clinical signs of suspected increased intracranial pressure On treatment for seizures or metabolic diseases Children with developmental delay Hypersensitivity to dexmedetomidine or nalbuphine

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group D<br>Dexmedetomidine IV at the end of surgery | Drug: Dexmedetomidine<br>* A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery<br>* Other names: Precedex;|
| Experimental: Group N<br>Nalbuphine IV at the end of surgery | Drug: Nalbuphine<br>* A single dose of 0.1 mg/kg IV nalbuphine at the end of surgery<br>* Other names: nalufin;|
| Placebo Comparator: Group C<br>Same volume of saline placebo IV at the end of surgery | Other: 0.9% saline<br>* Same volume of saline placebo IV at the end of surgery<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Pediatric Anesthesia Emergence Delirium (PAED) score | Emergence delirium (ED) will be measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scores for each of the five listed behaviours (The child makes eye contact with the caregiver/parent, the child's actions are Purposeful, the child is aware of his/her surroundings, the child is restless and the child is inconsolable) are added to achieve a total score (maximum score of 20). A score of ≥ 12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED | 1 hour postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC (Face, Legs, Activity, Cry, and Consolability) pain score. | The FLACC is a behavioural pain assessment scale for use for non-verbal or pre-verbal patients unable to self-report their level of pain. Rate your child in each of the five measurement categories, add together, and document total pain score (0 - 10), score 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain. | 1 hour postoperative |