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NCT04614259 Clinical Trial

Perioperative Pain Management for Cleft Lip in Children

Perioperative Complication Pain Clinical Trial

Official title:
Perioperative Pain Management for Cleft Lip Repair in Children, Bilateral Infraorbital Nerve Block Versus Conventional Methods( Combined IV Fentanyl With Peri Incisional Infiltration). A Randomized Comparative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04614259
Other study ID # N 49-2018/Ms
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 15, 2020
Est. completion date December 2020

Study information
Verified date November 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 76
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 3 Years
Eligibility 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: - 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 .

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bupivacain
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 Product:
• i.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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

References & Publications (5)

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.

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. Review. — View Citation

Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. — View Citation

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. — View Citation

Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative opioid consumption Total rescue doses of morphine 24 huors