Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection (RCT)

The Effect of Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized Clinical Trial

The Effect of Ibuprofen, Paracetamol versus Placebo on Pain during Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized clinical trial

Study Overview

• Status: Unknown
• Conditions: Pain Relief; Analgesic Drugs
• Intervention / Treatment: Drug: Ibuprofen; Drug: paracetamol; Dietary supplement: A fruit-flavored orange color placebo solution

Detailed Description

1. Diagnosis:

1. Diagnostic chart will be filled with personal, medical and dental history. DMF and def.
2. Clinical examination (intra oral and extra oral) will be done by mirror and probe to assess the inclusion criteria. All materials will be packaged in sterilizations wraps and autoclave following the required bio safety standards.

2. Intervention:

Experimental Groups:

Group 1: Ibuprofen suspension (Ibufen®, 100 mg/5 mL; fruit flavored, orange colour, Abbott). Group 2: Paracetamol (Calpol™, 250 mg/5 mL; fruit flavored, orange color, GlaxoSmithKline).

Comparative Group:

Group 3: A fruit-flavored orange color placebo solution.

Clinical procedure:

1. The drugs in all of the groups will be prepared in a fruit-flavored solution of the same color and scent.
2. Patients will be blind to one of the three pre-treatment drug groups.
3. Containers of each solution will be prepared and number-coded with the slips of paper by the assistant supervisor. The containers will be the same for all treatment groups except for the number coded with slips of paper.
4. Both the researcher and the child/parent will be blind to the content of the container.
5. The assigned solution will be taken by the patient at various times before administration of the local anesthetic agent. Ibuprofen 30 min before injection of local anesthesia paracetamol 60 min before injection of local anesthesia Placebo solution 60 min before injection of local anesthesia
6. The time of the preoperative solution administration will be recorded on the data sheet.
7. Topical anesthesia in the form of benzocaine gel 20% will be applied to the dried mucosa. All the children will be given 2% lidocaine with a 1:80,000 epinephrine injection for local anesthesia sufficient for obtaining adequate anesthesia.
8. All teeth will be extracted with a minimum of surgical trauma in an uncomplicated fashion.

Recording data

1. Pain scores will be recorded in the Pediatric Dental Clinic using a five-face scale that had been previously validated.
2. This scale has shown good construct validity as a self-report pain measure. It measures an affective dimension of a child's pain experience after injection and teeth extraction and is used in children aged 7-12 years.
3. It is easy to use and giving consistent scores from 0 to 4. It can be used for the subjective evaluation of feelings after the performance of painful dental procedures.
4. The child will be shown to a set of five cartoon faces with varying facial expressions ranging from a smile/laughter to tears. The scores given are: (0) No sign of pain. (1) Mild pain. (2) Moderate pain. (3) Severe pain. (4) Very severe pain.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children aged 7-12 years who need extractions under local anesthesia.
2. Those having a parent/guardian to understand and comply with the requirements of the protocol and able to fill an appropriate written informed consent.
3. Children and parents who agree to wait for the stipulated time before and after the extraction.

Exclusion Criteria:

1. Children with acute pain.
2. Patients taking analgesics within 5 hours prior to the dental extraction.
3. Patients with a history of prolonged bleeding, platelet disorders, hypersensitivity, or allergic reactions to analgesics or any of the drugs tested.
4. Patients without a home telephone or without parental supervision for the post- operative period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; Ibuprofen suspension (Ibufen®, 100 mg/5 mL; fruit flavored, orange colour, Abbott) will be given 30 min before injection of local anesthesia. Then pain scores will be recorded from 0-4.	Drug: Ibuprofen; It is a pre-analgesic will be taken before painful procedures.; Other Names: Ibufen®
Experimental: intervention; Paracetamol (Calpol™, 250 mg/5 mL; fruit flavored, orange color, GlaxoSmithKline) will be given 60 min before injection of local anesthesia.Then pain scores will be recorded from 0-4.	Drug: paracetamol; it is a pre-analgesic drug will be taken before painful procedure.; Other Names: calpol®
Placebo Comparator: comparator; A fruit-flavored orange color placebo solution will be given 60 min before injection of local anesthesia.Then pain scores will be recorded from 0-4.	Dietary supplement: A fruit-flavored orange color placebo solution; orange juice as a comparative group.; Other Names: orange juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
categorical score	mild, moderate, sever, very sever	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
binary	yes or no	1 day

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: fatma A. Elshehaby, Professor, Cairo University

Publications and helpful links

General Publications

• Gazal G, Mackie IC. A comparison of paracetamol, ibuprofen or their combination for pain relief following extractions in children under general anaesthesia: a randomized controlled trial. Int J Paediatr Dent. 2007 May;17(3):169-77. doi: 10.1111/j.1365-263X.2006.00806.x.

Helpful Links

• Description paper

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 11, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: RAElshenawy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: i will be available after finished

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No