Clinical trial

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

Name

17300616

Description

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.

Trial arms

Trial start

2021-06-20

Estimated PCD

2025-05-05

Trial end

2025-05-20

Status

Recruiting

Phase

Early phase I

Treatment

Dexmedetomidine

A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery

Arms:

Group D

Other names:

Precedex

Nalbuphine

A single dose of 0.1 mg/kg IV nalbuphine at the end of surgery

Arms:

Group N

Other names:

nalufin

0.9% saline

Same volume of saline placebo IV at the end of surgery

Arms:

Group C

Other names:

Normal saline

Size

Primary endpoint

the Pediatric Anesthesia Emergence Delirium (PAED) score

1 hour postoperative

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2024-05-17

1 organization

2 products

1 indication

Organization

Product

Indication

Product