Pain Management Following Dental Treatment Under General Anesthesia

NCT ID: NCT06574516

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2023-04-09

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Study group 1 (bimodal)

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

Group Type: EXPERIMENTAL

Ibuprofen 200 mg

Intervention Type: DRUG

Ibuprofen every 8 hours for three days post operatively

paracetamol

Intervention Type: DRUG

Paracetamol PRN for three days

study group 2

Participants were given Ibuprofen three times daily for 3 days

Group Type: EXPERIMENTAL

Ibuprofen 200 mg

Intervention Type: DRUG

Ibuprofen every 8 hours for three days post operatively

Control group

Paracetamol PRN based on parental assessment of pain

Group Type: ACTIVE_COMPARATOR

paracetamol

Intervention Type: DRUG

Paracetamol PRN for three days

Interventions

Ibuprofen 200 mg

Ibuprofen every 8 hours for three days post operatively

Intervention Type: DRUG

paracetamol

Paracetamol PRN for three days

Intervention Type: DRUG

Other Intervention Names

Brufen; Panadol

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: collaborator

King Abdullah University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

king Abdulla University Hospital

Irbid, , Jordan

Countries

Jordan

Other Identifiers

448-2021

Identifier Type: -

Identifier Source: org_study_id