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Status unknownNCT04614259Updated Nov 4, 2020

Perioperative Pain Management for Cleft Lip in Children

An interventional study of Bupivacain and i.v. analgesia in Perioperative Complication Pain, sponsored by Cairo University. Status unknown. Open to participants aged 6 Months to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-04.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
6 Months to 3 Years
Sex
All
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Study summary

Single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group C conventional group and 38 children group S infraorbital nerve block group.

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Conditions studied

  • Perioperative Complication Pain

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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 planned enrollment of 76 is above the median of 30 across 114 interventional studies indexed under Cleft Lip.

Browse Cleft Lip studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

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Who can participate

Ages eligible
6 Months to 3 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • good physical condition.
  • Age 6 months to 3 years.
  • Scheduled to undergo operations for cleft lip repair. Genders eligible for study are both .

Exclusion criteria

Exclusion Criteria:

  • Children posted for combined procedures like congenital heart correction with palatoplasty .
  • Parents refusal .
  • Bleeding disorders( platelets count \< 100.000 , international ratio >1.5).
  • Skin lesions or wounds at site of needle insertion .
  • Co-morbidities as congenital heart disease , lung pathology or central nervous system
  • Known hypersensitivity to local anesthetics or opioids .
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    intravenous analgesia

    Combination Product: i.v. analgesia

  • Experimental
    infraorbital nerve block

    Drug: Bupivacain

Interventions

  • DrugBupivacain

    The infraorbital foramen was located at the floor of the orbital rim at about the level of the pupil,The upper lip was folded back and a finger is placed externally at the level of the infraorbital foramen to prevent the needle from the cephalad insertion in the globe of the eye. A 27-gauge needle was bent about 70 degree to ease the insertion through the buccal mucosa over the maxillary process, towards the infraorbital foramen. After careful aspiration the local anesthetic was injected (injection of 3 ml 0.25% bupivacaine in 1:200.000 adrenaline ,1.5 ml on each side). \[104\] Pressure was needed to be applied for one minute to the area as there is loose adventitious tissue that can lead to swelling and ecchymosis

  • Combination producti.v. analgesia

    Using inhalational induction with sevoflurane as tolerated , atracurium 0.5mg/kg to facilitate endotracheal intubation and fentanyl 1 mcg/kg ,Mechanical ventilation was adjusted to maintain 30 to 35 mmHg end-tidal carbon dioxide, anesthesia was maintained with 1.5 % isoflurane and atracurium (0.1 mg/kg every 30 minutes) ,all patients were received intraoperative diclofenac sodium 0.5 mg/kg intramuscular . Blood pressure and heart rate were measured 5 minutes after endotracheal intubation and every 15 minutes till recovery from the anesthesia then every 15 min in the postoperative care unite for 30 minutes

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What researchers measure

Primary outcomes

  1. Postoperative opioid consumption

    Total rescue doses of morphine

    Time frame: 24 huors

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available. PubMed 460932 ↗
  • Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947. PubMed 16118385 ↗
  • Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
  • Doyle E, Hudson I. Anesthesia for primary repair of cleft lip and cleft palate: a review of 244 procedures. Paediatr Anaesth 1992; 2: 139-145.
  • Takemura H, Yasumoto K, Toi T, Hosoyamada A. Correlation of cleft type with incidence of perioperative respiratory complications in infants with cleft lip and palate. Paediatr Anaesth. 2002 Sep;12(7):585-8. doi: 10.1046/j.1460-9592.2002.00906.x. PubMed 12358652 ↗

Individual participant data

Plan to share: No — Do not share

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04614259
Lead sponsor
Cairo University
Responsible party
Mohamed Elsonbaty (Principal investigator, Cairo University) — Principal investigator
First posted
Nov 3, 2020
Start date
Nov 15, 2020 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Nov 4, 2020

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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