Back to resultsA Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation
Primary Purpose
Cleft Palate
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Nalbuphine
0.9% saline
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Palate
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
Sites / Locations
- Omar SolimanRecruiting
- Assiut university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group D
Group N
Group C
Arm Description
Dexmedetomidine IV at the end of surgery
Nalbuphine IV at the end of surgery
Same volume of saline placebo IV at the end of surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04928391
Brief Title
A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2021 (Actual)
Primary Completion Date
May 5, 2024 (Anticipated)
Study Completion Date
May 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group D
Arm Type
Experimental
Arm Description
Dexmedetomidine IV at the end of surgery
Arm Title
Group N
Arm Type
Experimental
Arm Description
Nalbuphine IV at the end of surgery
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Same volume of saline placebo IV at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Other Intervention Name(s)
nalufin
Intervention Description
A single dose of 0.1 mg/kg IV nalbuphine at the end of surgery
Intervention Type
Other
Intervention Name(s)
0.9% saline
Other Intervention Name(s)
Normal saline
Intervention Description
Same volume of saline placebo IV at the end of surgery
Primary Outcome Measure Information:
Title
the Pediatric Anesthesia Emergence Delirium (PAED) score
Description
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
Time Frame
1 hour postoperative
Secondary Outcome Measure Information:
Title
FLACC (Face, Legs, Activity, Cry, and Consolability) pain score.
Description
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.
Time Frame
1 hour postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Soliman, MD
Phone
01101266040
Email
omarmakram347@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Soliman
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Omar Soliman
City
Assiut
State/Province
Assuit
ZIP/Postal Code
Assuit universi
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Soliman
Phone
01101266040
Email
omarmakram347@yahoo.com
Facility Name
Assiut university hospital
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19854614
Citation
Milic M, Goranovic T, Knezevic P. Complications of sevoflurane-fentanyl versus midazolam-fentanyl anesthesia in pediatric cleft lip and palate surgery: a randomized comparison study. Int J Oral Maxillofac Surg. 2010 Jan;39(1):5-9. doi: 10.1016/j.ijom.2009.09.007. Epub 2009 Oct 24.
Results Reference
result
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A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation
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