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Pre-emptive Analgesic Administration in Primary Tooth Extraction

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ClinicalTrials.gov Identifier: NCT03786029
Recruitment Status : Completed
First Posted : December 24, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Nabih Raslan, 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.


Condition or disease Intervention/treatment Phase
Local Anesthesia Tooth Extraction Drug: Acetaminophen Drug: Placebo Drug: Ibuprofen Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, randomized placebo-controlled trial, comparing three groups.
Masking: Double (Participant, Investigator)
Masking Description: The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A (Acetaminophen)
22 children will receive 320mg (10ml) 30 minutes before the local anesthesia injection.
Drug: Acetaminophen

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.

Other Name: A

Placebo Comparator: B (Placebo)
22 children will receive 10ml 30 minutes before the local anesthesia injection.
Drug: Placebo

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.

Other Name: B

Experimental: C (Ibuprofen)
22 children will receive 200mg (10ml) 30 minutes before the local anesthesia injection.
Drug: Ibuprofen

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.

Other Name: C




Primary Outcome Measures :
  1. Assessment pain related to the injection of the local anesthesia using WBFS. [ Time Frame: 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.


  2. Post operative pain assessment using WBFS. [ Time Frame: 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 :
  1. Evaluate the parents' satisfaction using Likert fifth scale. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Exclusion Criteria:

Teeth with advanced root resorption (a third of the root at least)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786029


Locations
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Syrian Arab Republic
Tishreen University
Latakia, Syrian Arab Republic
Sponsors and Collaborators
Tishreen University
Investigators
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Study Chair: Nabih Raslan, Dr Tishreen University

Publications:

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Responsible Party: Nabih Raslan, Principal Investigator, Tishreen University
ClinicalTrials.gov Identifier: NCT03786029     History of Changes
Other Study ID Numbers: Tishreen - Pre-emptive
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Up to date, there is no decision about IPD sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nabih Raslan, Tishreen University:
Pre-emptive administration
Analgesic
Tooth extraction

Additional relevant MeSH terms:
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Anesthetics
Acetaminophen
Ibuprofen
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action