MedTrace Logo

Perioperative Pain Management for Cleft Lip in Children

NCT04614259 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2020-11-04

No results posted yet for this 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.

Conditions

  • Perioperative Complication Pain

Interventions

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2020-12-31
Completion
2020-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614259 on ClinicalTrials.gov