Pre-emptive Analgesic Administration in Primary Tooth Extraction

Study Overview
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Brief Summary
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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
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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: Acetaminophen syrup: 160mg/5ml Placebo solution Ibuprofen suspension: 100mg/5ml

Official Title
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Comparison of Pre-emptive Ibuprofen, Acetaminophen, and Placebo Administration in Reducing Local Anesthesia Injection Pain and Post-operative Pain in Primary Tooth Extraction. A Clinical Study

Conditions
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Local Anesthesia, Tooth Extraction

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Placebo
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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. - Exclusion Criteria: Teeth with advanced root resorption (a third of the root at least)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Blinded, randomized placebo-controlled trial, comparing three groups.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A (Acetaminophen)<br>22 children will receive 320mg (10ml) 30 minutes before the local anesthesia injection. | Drug: Acetaminophen<br>* Patients will receive 320mg (10ml) Acetaminophen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection. The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction. Pain will be re-evaluated 15 minutes after the extraction. The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home. Parents' satisfaction will be evaluated using Likert fifth scale.<br>* Other names: A;|
| Placebo Comparator: B (Placebo)<br>22 children will receive 10ml 30 minutes before the local anesthesia injection. | Drug: Placebo<br>* Patients will receive 10ml Strawberry Juice (placebo), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection. The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction. Pain will be re-evaluated 15 minutes after the extraction. The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home. Parents' satisfaction will be evaluated using Likert fifth scale.<br>* Other names: B;|
| Experimental: C (Ibuprofen)<br>22 children will receive 200mg (10ml) 30 minutes before the local anesthesia injection. | Drug: Ibuprofen<br>* Patients will receive 200mg (10ml) of Ibuprofen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection. The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction. Pain will be re-evaluated 15 minutes after the extraction. The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home. Parents' satisfaction will be evaluated using Likert fifth scale.<br>* Other names: C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment pain related to the injection of the local anesthesia using WBFS. | 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. | 30-60 seconds after injection of the local anesthesia. | 
| Post operative pain assessment using WBFS. | 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. | 10 minutes - 6 hours after the extraction. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the parents' satisfaction using Likert fifth scale. | 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. | 6 hours after extraction. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-emptive administration, Analgesic, Tooth extraction