Pain Management Following Dental Treatment Under General Anesthesia

The Influence Of Effective Post-Operative Pain Management Following Dental Treatment Under General Anesthesia On Parental Satisfaction And Patient Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ibuprofen 200 mg; Drug: paracetamol

Detailed Description

After ensuring the fulfillment of inclusion criteria, data were collected on three phases as follows:

Pre-Operative By interviewing the parents preoperatively during the waiting time, consent was obtained via a consent form , sociodemographic data (name, age, and date of the operation) were also collected using parental questionnaire .

Preoperative pain was measured using WBFPRS. Pre- and postoperative pain scales were explained to parents by the research assistant.

Intra-Operative Data were collected on anesthesia protocol , and dental treatment performed.

Anesthesia Protocol Data about anesthesia protocol were collected to ensure fulfilment of inclusion criteria, this includes mode of induction (IV or inhalational), tube type (nasal or oral), tube size, intra-operative medications (Dexamethasone and analgesia) doses and repetition , cases which did not fulfil the anesthesia protocol were excluded.

Dental Treatment Performed Data on dental procedures were collected including number of extracted teeth, location of extracted teeth (anterior, posterior), and length of dental procedure (in minutes)

Post-Operative Parents were interviewed in the hospital prior to discharge to assess pain 2 hours post operatively using parent's postoperative pain measure (PPPM).

Phone interviews were done to assess postoperative pain using PPPM at home by the same parent at the following intervals: on the night of the procedure, the next day before bed and on the third day before bed. Adherence of parents to pain control prescription was also reported.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan, 21166
    • king Abdulla University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group 1 (bimodal); participants were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days,	Drug: Ibuprofen 200 mg; Ibuprofen every 8 hours for three days post operatively; Other Names: Brufen; Drug: paracetamol; Paracetamol PRN for three days; Other Names: Panadol
Experimental: study group 2; Participants were given Ibuprofen three times daily for 3 days	Drug: Ibuprofen 200 mg; Ibuprofen every 8 hours for three days post operatively; Other Names: Brufen
Active Comparator: Control group; Paracetamol PRN based on parental assessment of pain	Drug: paracetamol; Paracetamol PRN for three days; Other Names: Panadol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of treated children	Using Childhood Oral Health Impact Scale (ECOHIS), by comparing pre and postoperative scores, lower scores mean better quality of life	2 weeks post operative

Collaborators and Investigators

• Sponsor: King Abdullah University Hospital
• Collaborators: Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): August 25, 2022
• Study Completion (Actual): April 9, 2023

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: general anesthesia; post operative pain; extraction
• 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: 448-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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