Perioperative Pain Management for Cleft Lip in Children

NCT ID: NCT04614259

Last Updated: 2020-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2020-12-31

Brief 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.

Conditions

Perioperative Complication Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

intravenous analgesia

Group Type: EXPERIMENTAL

i.v. analgesia

Intervention Type: COMBINATION_PRODUCT

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

infraorbital nerve block

Group Type: EXPERIMENTAL

Bupivacain

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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 .

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Elsonbaty

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 460932 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16118385 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 12358652 (View on PubMed)

Other Identifiers

N 49-2018/Ms

Identifier Type: -

Identifier Source: org_study_id