Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574516
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
Pain Management Following Dental Treatment Under General Anesthesia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Influence Of Effective Post-Operative Pain Management Following Dental Treatment Under General Anesthesia On Parental Satisfaction And Patient Outcomes
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 parents postoperative pain measure PPPM on the first second and third days
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 parents 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 parents 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
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 parents 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None