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Clonidine for Infra-orbital Nerve Block During Pediatric Cleft Lip Revision Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05790044
Recruitment Status : Not yet recruiting
First Posted : March 29, 2023
Last Update Posted : March 29, 2023
Information provided by (Responsible Party):
RAGAA AHMED HERDAN, Assiut University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double blind
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Bupivacaine
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.
Drug: Clonidine
intra-oral infra-orbital nerve block with bupivacaine and clonidine

Primary Outcome Measures :
  1. Pain score [ Time Frame: 24 hours ]
    FLACC pain score as 1-3 = Mild discomfort; 4-6 = Moderate pain; 7-10 = Severe pain

Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: 2 hours ]
    Intraoperative heart rate monitoring

  2. 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

  3. rescue analgesia [ Time Frame: 24 hours ]
    Total rescue doses of paracetamol IV over 24 hours postoperatively used in each group.

  4. 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

Inclusion Criteria:

  • Age: 1-7 years old.
  • Gender: both.
  • ASA physical status I-II
  • Children scheduled to undergo cleft lip revision surgeries.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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

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Contact: Ragaa Herdan, assis prof 01001741748 ragaanesthesia@yahoo.com
Contact: Hany Ibrahem, professor 01005203980 elmorabaa@yahoo.com

Sponsors and Collaborators
Assiut University
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Principal Investigator: Ragaa Herdan, professor faculty of medicine assiut university egypt
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Responsible Party: RAGAA AHMED HERDAN, professor, Assiut University
ClinicalTrials.gov Identifier: NCT05790044    
Other Study ID Numbers: 25353465363643
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

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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
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action