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Trials / Completed

CompletedNCT06574516

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
118 (actual)
Sponsor
King Abdullah University Hospital · Academic / Other
Sex
All
Age
4 Years – 8 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGIbuprofen 200 mgIbuprofen every 8 hours for three days post operatively
DRUGparacetamolParacetamol PRN for three days

Timeline

Start date
2021-11-04
Primary completion
2022-08-25
Completion
2023-04-09
First posted
2024-08-28
Last updated
2024-09-04

Locations

1 site across 1 country: Jordan

Source: ClinicalTrials.gov record NCT06574516. Inclusion in this directory is not an endorsement.