Pain Management Following Dental Treatment Under General Anesthesia

NCT06574516 | Completed

• 1 other identifier: 448-2021
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to test the efficacy of postoperative pain management for cases undergoing extractions of primary teeth under GA using a validated measure. Children undergoing extraction of at least one primary molar under general anesthesia GA at King Abdullah University Hospital (KAUH) were randomly assigned into three groups: study group (1) were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days, study group (2) were given Ibuprofen three times daily for 3 days, study group (3) were given Paracetamol prn for 3 days. pain was assessed using parent's postoperative pain measure (PPPM) on the first, second and third days.

Conditions

Pain

Keywords

post operative pain; extraction; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Efficacy of pain control using different medications

  Reduction in pain scores using the parental post operative pain measure, by comparing scores immediately post operative with scores on subsequent days. higher scores indicate worse pain

  3 days post operative

Secondary Outcomes (1)

• Quality of life of treated children

  2 weeks post operative

Study Arms (3)

Study group 1 (bimodal)

EXPERIMENTAL

participants were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days,

Drug: Ibuprofen 200 mg; Drug: paracetamol

study group 2

EXPERIMENTAL

Participants were given Ibuprofen three times daily for 3 days

Drug: Ibuprofen 200 mg

Control group

ACTIVE COMPARATOR

Paracetamol PRN based on parental assessment of pain

Drug: paracetamol

Interventions

Ibuprofen 200 mg DRUG

Ibuprofen every 8 hours for three days post operatively

Also known as: Brufen

Study group 1 (bimodal); study group 2

paracetamol DRUG

Paracetamol PRN for three days

Also known as: Panadol

Control group; Study group 1 (bimodal)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Fit and healthy patients, ASA I without cognitive or mental disabilities.
• Aged between 4-8 years.
• No preoperative moderate to severe pain.
• Not receiving pain medication prior to GA.
• Not allergic to any of the prescribed medications.
• Undergoing at least one posterior tooth extraction.
• Parent signed the consent form.

You may not qualify if:

• Children requiring extraction of permanent molars to ensure standardization.
• Patients who had no extractions at all.
• Cases of difficult intubation as pain of difficult intubation could be confused with dental pain
• Cases where it was necessary to repeat intra-operative analgesic medication (Fentanyl).
• Diclofenac sodium suppository was not given at the end of the procedure.
• Anesthetist did not follow the standardized anesthesia protocol existing in KAUH like cases where a sedative medication like Ketamine was given preoperatively.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

king Abdulla University Hospital

Irbid, 21166, Jordan

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: blinding of investigators and outcome assessor was possible however no blinding of the participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: November 4, 2021
• Primary Completion: August 25, 2022
• Study Completion: April 9, 2023
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)