Perioperative Pain Management for Cleft Lip in Children
Primary Purpose
Perioperative Complication Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bupivacain
i.v. analgesia
Sponsored by
About this trial
This is an interventional prevention trial for Perioperative Complication Pain
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 .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
intravenous analgesia
infraorbital nerve block
Arm Description
Outcomes
Primary Outcome Measures
Postoperative opioid consumption
Total rescue doses of morphine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04614259
Brief Title
Perioperative Pain Management for Cleft Lip in Children
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Complication Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intravenous analgesia
Arm Type
Experimental
Arm Title
infraorbital nerve block
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
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
Combination Product
Intervention Name(s)
i.v. analgesia
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Total rescue doses of morphine
Time Frame
24 huors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 .
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Do not share
Citations:
PubMed Identifier
460932
Citation
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.
Results Reference
background
PubMed Identifier
16118385
Citation
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.
Results Reference
background
Citation
Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
12358652
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. doi: 10.1046/j.1460-9592.2002.00906.x.
Results Reference
background
Learn more about this trial
Perioperative Pain Management for Cleft Lip in Children
We'll reach out to this number within 24 hrs