Pre-emptive Analgesic Administration in Primary Tooth Extraction
- Conditions
- Local AnesthesiaTooth Extraction
- Interventions
- Registration Number
- NCT03786029
- Lead Sponsor
- Tishreen University
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- Teeth with an abscess or infection exceeding one-third of the interradicular area (not exceeding the oral cavity) 2. Unrestorable decayed teeth. 3. Teeth with periapical / interradicular lesions.
Teeth with advanced root resorption (a third of the root at least)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B (Placebo) Placebo 22 children will receive 10ml 30 minutes before the local anesthesia injection. A (Acetaminophen) Acetaminophen 22 children will receive 320mg (10ml) 30 minutes before the local anesthesia injection. C (Ibuprofen) Ibuprofen 22 children will receive 200mg (10ml) 30 minutes before the local anesthesia injection.
- Primary Outcome Measures
Name Time Method Assessment pain related to the injection of the local anesthesia using WBFS. 30-60 seconds after injection of the local anesthesia. The Wong-Baker Faces Pain Rating Scale (WBFS) is a pain scale that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Immediately after the injection, the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale, WBFS.Post operative pain assessment using WBFS. 10 minutes - 6 hours after the extraction. After 10minutes from the injection and immediately after the extraction, the child will be asked to point to the face that fits the degree of pain on the same scale.
Re-evaluate the pain after 15minutes from the extraction.
The scale will be given to the parents to evaluate the pain post-extraction after an hour to 6 hours while the child is at home.
- Secondary Outcome Measures
Name Time Method Evaluate the parents' satisfaction using Likert fifth scale. 6 hours after extraction. After the post-operation pain assessment is being done by the parents, the Likert fifth scale is used to determined the degree of parents satisfaction by choosing one of the following degrees: strongly agree, agree, neutral, disagree, strongly disagree.
Trial Locations
- Locations (1)
Tishreen University
🇸🇾Latakia, Syrian Arab Republic