This study investigates preliminary investigations, whether a pre-emptive analgesia administration reduce pain during pulp therapy.
This randomized, double-blind, placebo-controlled trial is planned to compare the efficacy of the pre-emptive administration of ibuprofen, acetaminophen and placebo in reducing pain during pulp therapy in children. Children ages 6–10, presenting at the pediatric clinic of Yazd faculty of dentistry, experiencing spontaneous pain of upper primary molars and with out any systemic diseases or allergic reaction, are considered potential candidates. Seventy-five children are included based on inclusion criteria. The patients are administered a pre-emptive single dose of either: (i) fruit flavored Ibuprofen suspension (100 mg⁄5 mL); 10 mg/kg/dose or (ii) fruit flavored Acetaminophen elixir (120 mg⁄5 mL); 15 mg/kg/dose or (iii) placebo one hour before treatment. Following administration of local anesthesia, pulp therapy is performed. Patients record pain intensity right after the procedure on a five point visual analogue scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111017935N3
Registration date:2015-04-13, 1394/01/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-13, 1394/01/24
Registrant information
Name
Zahra Bahrololoomi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences-Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
zbahrololoom@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences of Yazd
Expected recruitment start date
2015-04-01, 1394/01/12
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pre-emptive ibuprofen, acetaminophen, and placebo administration in reducing pain during upper primary molar pulp therapy
Public title
Use of analgesics in pain reduction in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: children ages 6–12, who has primary maxillary molar spontaneous pain; no history of any systemic disease (renal, liver or digestion diseases); no history of prolonged bleeding; no history of platelet disorders; no history of hypersensitivity or allergic reactions to analgesics or any of the drugs tested.
Exclusion criteria: Patients taking analgesics within 5 hours prior to the dental procedure; uncooperative and anxious children.
Age
From 6 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
89195/165
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
79291
Health conditions studied
1
Description of health condition studied
Pain control during pulptherapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain during pulp therapy
Timepoint
Right after pulp therapy
Method of measurement
Five face Visual Scale
Secondary outcomes
1
Description
Severity of Pain
Timepoint
Right after pulp therapy
Method of measurement
Five face Visual Scale
Intervention groups
1
Description
Fruit flavored Ibuprofen suspension (100 mg⁄5 mL); 10 mg/kg/dose one hour before treatment.
Category
Treatment - Drugs
2
Description
Fruit flavored Acetaminophen elixir (120 mg⁄5 mL); 15 mg/kg/dose; one hour before treatment.
Category
Treatment - Drugs
3
Description
Fruit-flavored placebo solution; one hour before treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Narges Amrollahi
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Dr. Fateme Ezoddini Ardakani
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences of Yazd
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Narjes Amrollahi Bioki
Position
Postgraduate student of pediatric dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3726 7525
Fax
+98 35 3726 7525
Email
narges1amr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Dr. Zahra bahrololoomi
Position
Associate professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3624 0691
Fax
+98 35 3623 8561
Email
zbahrololoom@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Postgraduate student of pediatric dentistry
Full name of responsible person
Narjes Amrollahi Bioki
Position
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3726 7525
Fax
+98 35 3726 7525
Email
narges1amr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)