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
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.
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 →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.
Exclusion Criteria:
Drug: Dexmedetomidine +Bupivacaine
Drug: Magnesium Sulfate + Bupivacaine
Drug: Bupivacaine
infraorbital nerve block by dexmedetomidine plus bupivacaine
infraorbital nerve block by magnesium sulphate plus bupivacaine
infraorbital nerve block by bupivacaine only
first time to analgesic requirment
paracetamol will be given as the first rescue analgesia
Time frame: 1st 24 hour
Total amount of analgesics
Time frame: 1st 24 hours postoperatively
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
postoperative side effects
Time frame: 1st 24 hour postoperatively
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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Ain Shams University