Ainshams university hospitals
Cairo, Egypt
Location status: Recruiting
NCT Number: NCT07035314
The aim of this study is to compare the efficacy of adding paracetamol to systemic non-steroidal anti-inflammatory drugs (NSAIDs) versus adding dexamethasone as local infiltration to paracetamol on post tonsillectomy pain control.
Interested in participating?
Request Info4 year–10 year
All sexes
Interventional
Not applicable
Cairo, Egypt
Location status: Recruiting
A Prospective Randomized Controlled study. The study will be conducted at Ain Shams University hospital, Otolaryngology Department. Study period is 6 months from approval of the protocol. Study Participants will be recruited from outpatient ENT clinic, and ENT department inpatients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.
Other names: 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
Other names: 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.
Other names: 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.
Time frame: DAY 0 6h, 24h post-operatively and DAY 5 post-operatively
The primary endpoints that will be used is resting pain scores using virtual analogue scale; VAS score (0: no pain-10: worst pain) at DAY 0 after 6h, 24h and DAY 5 post-operatively. Where pain score will be measured at multiple points during the outcome intervals, the pain scores at the time closest to six and 24h will be used.
Time frame: 2 weeks post operatively
The percentage of the patients in group 1 and 2 that will need extra analgesia
Time frame: 2 weeks post operatively
Patient satisfaction and return to normal activity.
Time frame: 2 weeks post operatively
Adverse effects noticed such as nausea, vomiting, infection and post tonsillectomy bleeding.
Contact information is provided by the study sponsor or research team.
Ain Shams University
Other
The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain: A Prospective Randomized Controlled Study.
Acronym: NSAIDs
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04657549
Infections, Otorhinolaryngologic Diseases
Rovaniemi, Lapland, Finland
View Trial DetailsNCT03654742
Body Temperature Changes, Heat Stress Disorders
Turku, Finland
View Trial DetailsNCT04725305
Hemorrhage, Neurologic Manifestations
Houston, Texas, United States
View Trial DetailsNCT03793816
Handling, Hemorrhage
Vienna, Austria
View Trial Details