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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05109416
Other study ID # 59:4/2021
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 17, 2021
Est. completion date March 22, 2022

Study information

Verified date April 2022
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Tonsillectomy is one of most common performed surgical procedure in children . tonsillectomy or adenotonsillectomy have high incidence of Post operative pain , it is very important and significant problem because it can lead to decrease oral intake and dehydration


Description:

Tonsillectomy is one of the most common performed surgical procedure in children. Tonsillectomy or adenotonsillectomy have high incidence of Post operative pain incidence . There is still debate about the optimal analgesia for this common procedure , different methods have been described including intraoperative anesthetic pain regimens , adjustment of surgical technique , intraoperative local anesthetic injection and use of pharmacotherapy post operative . The main goal of the preventive analgesia is the pain releif with minimum side effect . The objective of this study is to investigate and compare the effect of Glossopharyngeal nerve block for relief of pain on children following adenotonsillectomy . This is prospective , double blinded , randomized study


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date March 22, 2022
Est. primary completion date March 5, 2022
Accepts healthy volunteers No
Gender All
Age group 7 Years to 15 Years
Eligibility Inclusion Criteria: - average weight is 10_50 kg - patient is generally stable - indication of tonsillectomy is recurrent tonsillitis - Ability to self report pain Exclusion Criteria: - Hypersensitivity to bupivacaine - Obstructive sleep apnea syndrome - Pulmonary or cardic diseases

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine Hydrochloride 0.5% Injection Solution
Local anesthetic
Saline 0.9%
Isotonic crystaloid

Locations

Country Name City State
Egypt Faculty of Medcine Minya

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The first call for analgesia Pain assessment using VAS scale In 24 hours
Secondary The analgesic consumption The total analgesic consumption for pain rest and swallowing In 24 hours
See also
  Status Clinical Trial Phase
Not yet recruiting NCT00733083 - A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients N/A
Withdrawn NCT00452738 - The Effect of Pre Surgery Dog Visits on Post Surgery Consumption of Pain Medication N/A