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CompletedNCT05624151Updated May 15, 2023

Dexmedetomidine Versus Magnesium Sulphate Added to Bupivacaine in Infraorbital Nerve Block for Perioperative Analgesia in Paediatric Patients for Cleft Lip Surgery

A Phase 3 interventional study of Dexmedetomidine +Bupivacaine and Magnesium Sulfate + Bupivacaine in Analgesia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 3 Months to 7 Years. Per ClinicalTrials.gov, last updated 2023-05-15.

Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
3 Months to 7 Years
Sex
All
01

Study summary

Regional analgesia is considered the cornerstone for postoperative analgesia in paediatric patients. One of the most common birth defects which require surgical intervention early in life is the cleft lip. Infraorbital nerve block (IONB) has been used for postoperative analgesia in this delicate and sensitive area.

As the assessment of pain may be very challenging especially in young children, the local anaesthetics administration can be a safe alternative to opioids.[2] However, the regional block after a single dose of local anaesthetic is of limited duration and efficacy. Hence, the coadministration of adjuvants with local anaesthetics may be helpful for potentiation of analgesic effect.

Infraorbital nerve block is a well-recognized regional anaesthetic technique which can provide intraoperative and postoperative pain relief in nasal endoscopic surgery and in some types of oral and dental surgery including cleft lip repair . The block may also be used to help diagnose neuralgia arising from the second division of the trigeminal nerve. The technique for infraorbital nerve blockade is most performed as it exits the infraorbital foramen just below the inferior orbital rim.Dexmedetomidine (DE) is a potent α2 adrenoreceptor agonist and it is highly selective for α2 adrenoreceptor seven times more than clonidine. Many studies documented a prolonged duration and rapid onset of sensory block with the perineural injection of DE. Dexmedetomidine has been introduced as an adjuvant to local anaesthetics in both neuroaxial and peripheral nerve blocks. [9, 10] perineural dexmedetomidine has shown to prolong the duration of postoperative analgesia in addition to reducing the opioid consumption. The exact mechanism of peripheral nerve block produced by α2 adrenoreceptor agonists includes central analgesia, anti-inflammatory effect.Another suggested mechanism is that DE may exert its action through blocking the hyperpolarization-activated cation current after the transient sodium influx. The effect of magnesium was first recognized for the treatment of arrhythmia and preeclampsia, and its effect on anaesthesia and analgesia has recently been recognized. Magnesium sulphate has also been used as an adjunct to anaesthesia in recent years. It is also an effective analgesic agent for perioperative pain. Research have also reported that the intraoperative use of magnesium is characterized by a reduced use of anaesthetics and muscle relaxants. Furthermore, opioid use, postoperative nausea and vomiting, hypertension, and shivering have met a decreased trend with the use of magnesium sulphate. In a study performed by (El-Emam and El motlb) in 2019 they compared the efficacy of dexamethasone versus dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided infraorbital nerve block in paediatric patients scheduled for cleft lip repair. they noticed that dexmedetomidine produced a more prolonged duration of analgesia and a lower pain score and increased sedation than produced by dexamethasone. Also, they found that Both dexamethasone and dexmedetomidine were tolerable with no significant difference regarding the incidence of postoperative nausea and vomiting or intraoperative hemodynamic changes.Aim of the work:

The purpose of this randomized controlled double-blind study is to compare the efficacy of Dexmedetomidine or Magnesium sulphate as adjuvants for bupivacaine in infraorbital nerve block in paediatric patients scheduled for cleft lip repair.

02

Conditions studied

  • Analgesia

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03

In context

Cleft Lip

162 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.

This study's enrollment of 75 is above the median of 30 across 114 interventional studies indexed under Cleft Lip.

Browse Cleft Lip studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients who will be scheduled for indicated cleft lip surgery. • physical status American Society of Anesthesiologists (ASA) I or II.

Exclusion criteria

Exclusion Criteria:

  • failure to gain the consent from parents
  • allergy to any of drugs used
  • coagulopathy
  • thrombocytopenia
  • history of any lower or upper airway disorders
  • history of sleep apnea syndrome with a suspected need for postoperative ventilation
  • any wound or infection related to puncture site
  • major illness failure to gain the consent of parents.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Active comparator
    general anesthesia+ infraorbital nerve block by dexmedetomidine plus bupivacaine

    Drug: Dexmedetomidine +Bupivacaine

  • Active comparator
    general anesthesia+ infraorbital nerve block by magnesium sulphate plus bupivacaine

    Drug: Magnesium Sulfate + Bupivacaine

  • Active comparator
    general anesthesia+infraorbital nerve block by bupivacaine only

    Drug: Bupivacaine

Interventions

  • DrugDexmedetomidine +Bupivacaine

    infraorbital nerve block by dexmedetomidine plus bupivacaine

  • DrugMagnesium Sulfate + Bupivacaine

    infraorbital nerve block by magnesium sulphate plus bupivacaine

  • DrugBupivacaine

    infraorbital nerve block by bupivacaine only

06

What researchers measure

Primary outcomes

  1. first time to analgesic requirment

    paracetamol will be given as the first rescue analgesia

    Time frame: 1st 24 hour

Secondary outcomes

  1. Total amount of analgesics

    Time frame: 1st 24 hours postoperatively

  2. pain score (FLACC Score) face, leg , cry, activity ,conslolability

    assess pain in patients (ranging from 0-10, where 0 = no pain, 10 = worst pain)

    Time frame: 1st 24 postoperatively

  3. postoperative side effects

    Time frame: 1st 24 hour postoperatively

07

Study locations

1 site
  • Ain Shams University hospitals
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05624151
Lead sponsor
Ain Shams University
Responsible party
Amin Mohammed Alansary Amin Ahmed Helwa (Assistant professor, Ain Shams University) — Principal investigator
First posted
Nov 21, 2022
Start date
Nov 25, 2022
Primary completion
May 2, 2023
Completion
May 2, 2023
Last update
May 15, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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