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Clinical Trial Summary

Brief Summary:

Aims: The objective of the current study will be to compare the effectiveness of Ibuprofen, Acetaminophen, and Placebo on reducing injection pain and post-operative pain in primary tooth extraction, and to compare the parents' satisfaction.

Design: This will be a blinded, randomized placebo-controlled trial including sixty six cooperative children, aged 6-8 years old.


Clinical Trial Description

Background and Aims: The pain could be a problem for the patients during the first few hours after the extraction because of both soft and hard tissues trauma during the operation, despite that the local anesthesia will last for a long time in most of the cases.

There are no enough studies that ensure the validity of giving any analgesic in reducing injection pain and post-operative pain in primary tooth extraction so far.

Design: This will be a blinded, randomized placebo-controlled trial including sixty six cooperative children, aged 6-8 years old, randomly assigned to one of three groups to receive one of the oral suspension drugs, that have the same colour and taste, via pre-calibrated medication bottles, which are identical, numbered and containing the same amount of pre-calibrated dosages, as per the following portions:

1. Acetaminophen syrup: 160mg/5ml

2. Placebo solution

3. Ibuprofen suspension: 100mg/5ml ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03786029
Study type Interventional
Source Tishreen University
Contact
Status Completed
Phase Phase 2/Phase 3
Start date April 1, 2019
Completion date June 10, 2019

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