Clonidine for Infra-orbital Nerve Block During Pediatric Cleft Lip Revision Surgeries
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|ClinicalTrials.gov Identifier: NCT05790044|
Recruitment Status : Not yet recruiting
First Posted : March 29, 2023
Last Update Posted : March 29, 2023
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Pain in children is usually an undertreated entity. Undertreating perioperative pain could lead to various metabolic, physiologic, and neurophysiological responses. The usual means of management i.e., opioids may increase the incidence of respiratory depression in this age group. Adequate postoperative analgesia in children is a vital part of perioperative care. Good pain relief minimizes oxygen requirement, reduces cardio-respiratory demands, and promotes early ambulation and recovery. Regional block given preoperatively in combination with general anesthesia provides good preemptive analgesia. It is associated with hemodynamic stability, rapid and complete recovery, and reduced analgesic requirement in postoperative period.
Type of the study: A prospective randomized controlled double-blind study.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Bupivacaine Drug: Clonidine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||double blind|
|Official Title:||Clonidine for Intra-oral Infra-orbital Nerve Block During Pediatric Cleft Lip Revision Surgeries: Randomized Controlled Double-blind Study|
|Estimated Study Start Date :||June 1, 2023|
|Estimated Primary Completion Date :||October 1, 2024|
|Estimated Study Completion Date :||March 1, 2025|
Active Comparator: Group Placebo
Children will receive intra-oral infra-orbital nerve block using bupivacaine 0.2% after induction of general anesthesia and before starting surgical procedure. Total volume of 1 ml each side.
intra-oral infra-orbital nerve block with bupivacaine alone
Active Comparator: Group Clonidine
Children will receive intra-oral infra-orbital nerve block using bupivacaine 0.2% and clonidine 1 ug/kg after induction of general anesthesia and before starting surgical procedure. Total volume of 1 ml each side.
intra-oral infra-orbital nerve block with bupivacaine and clonidine
- Pain score [ Time Frame: 24 hours ]FLACC pain score as 1-3 = Mild discomfort; 4-6 = Moderate pain; 7-10 = Severe pain
- Heart Rate [ Time Frame: 2 hours ]Intraoperative heart rate monitoring
- Sedation Score [ Time Frame: 6 hours ]1. Awake and alert. 2. Sleeping but easily arouses to voice or light touch. 3. Arouses to loud voice or shaking. 4. Arouses with painful stimuli only. 5. Unarousable
- rescue analgesia [ Time Frame: 24 hours ]Total rescue doses of paracetamol IV over 24 hours postoperatively used in each group.
- 5-point Likert scale Satisfaction Score [ Time Frame: 24 hours ]1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very dissatisfied
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|Ages Eligible for Study:||1 Year to 7 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age: 1-7 years old.
- Gender: both.
- ASA physical status I-II
- Children scheduled to undergo cleft lip revision surgeries.
- History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult.
- Parents refusal.
- Hypersensitivity to any local anesthetics.
- Bleeding diathesis.
- Children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system disorders.
- Skin lesions or wounds at the puncture site of the proposed block.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05790044
|Contact: Ragaa Herdan, assis email@example.com|
|Contact: Hany Ibrahem, firstname.lastname@example.org|
|Principal Investigator:||Ragaa Herdan, professor||faculty of medicine assiut university egypt|
|Responsible Party:||RAGAA AHMED HERDAN, professor, Assiut University|
|Other Study ID Numbers:||
|First Posted:||March 29, 2023 Key Record Dates|
|Last Update Posted:||March 29, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Stomatognathic System Abnormalities
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action