Preemptive Analgesia Using Intravenous Paracetamol

Preemptive Analgesia Using Intravenous Paracetamol in Dental Sitting

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.

Study Overview

• Status: Completed
• Conditions: Adverse Anesthesia Outcome
• Intervention / Treatment: Drug: Placebo; Drug: Paracetamol

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Active Comparator: Preemptive Paracetamol	Drug: Paracetamol; Paracetamol
Active Comparator: Post surgery Paracetamol	Drug: Paracetamol; Paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain measure in numerical scale	Post operative Pain measure in numerical scale from 1 to 10	1-24 hours

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Study Chair: mira koch, Ethicla Committee Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: August 21, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Estimate): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 30, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Dental treatment; Postoperative pain; Paracetamol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: BnaiZionMC-16-LG-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES