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Preemptive Analgesia Using Intravenous Paracetamol

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ClinicalTrials.gov Identifier: NCT02884921
Recruitment Status : Completed
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
LUIS.GAITINI, Bnai Zion Medical Center

Brief Summary:

Dental treatment for children should be done in a calm atmosphere and without pain. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models.

There are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.

The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention of postoperative pain in children undergoing dental treatment.


Condition or disease Intervention/treatment Phase
Adverse Anesthesia Outcome Drug: Paracetamol Drug: Placebo Not Applicable

Detailed Description:

Dental treatment for children should be done in a calm atmosphere and without pain in purpose to achieve a positive feelings and response towards dental treatment.Postoperative pain is the main issue which may cause a negative attitude of the child to dental treatment in future appointment. One of the affective options to deal with this pain is to give analgesic drug before the initiative of treatment which should continue its effect during and may also after treatment which is known as "preemptive analgesia. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models. In double blind clinical trials single or multiple dose of intravenous paracetamol, generally provided significantly better analgesic effect than placebo treatment in adults' patients who had undergone dental, orthopedic or gynecological surgery. There is considerable evidence that the analgesic effect of paracetamol is central and is due to activation of descending serotonergic pathways, but its primary site of action may still be inhibition of prostaglandin synthesis by its selective inhibition of Cox-2 isoenzyme.

At the best of the investigators knowledge, there are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.

The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention or modification of postoperative pain in children undergoing dental treatment.

The primary outcome of this study is to investigate the post dental treatment analgesic effect of intravenous paracetamol in children when administered before compared to after dental treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Preemptive Analgesia Using Intravenous Paracetamol in Dental Sitting
Study Start Date : April 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Active Comparator: Preemptive Paracetamol
Preemptive Paracetamol
Drug: Paracetamol
Paracetamol

Active Comparator: Post surgery Paracetamol
Post surgery Paracetamol
Drug: Paracetamol
Paracetamol

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Pain measure in numerical scale [ Time Frame: 1-24 hours ]
    Post operative Pain measure in numerical scale from 1 to 10



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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • All children who require a wide treatment of caries
  • Children of high score of anxious or who is stressfully

Exclusion criteria:

  • Contraindication for paracetamol
  • Renal or hepatic insufficiency
  • Patient have history of allergy for paracetamol
  • Anemia of Hgb less than 10 gr/DL

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): NCT02884921


Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
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Study Chair: mira koch Ethicla Committee Bnai Zion Medical Center

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Responsible Party: LUIS.GAITINI, MD, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT02884921    
Other Study ID Numbers: BnaiZionMC-16-LG-008
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by LUIS.GAITINI, Bnai Zion Medical Center:
Postoperative pain
Dental treatment
Paracetamol
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics