The effect of platelet-rich fibrin on pain and recovery after tonsil surgery in children

ISRCTN	ISRCTN11759959
DOI	https://doi.org/10.1186/ISRCTN11759959
Sponsor	Kuwait Institution of Medical Specialization (KIMS)
Funder	Investigator initiated and funded

Submission date: 15/08/2026
Registration date: 01/09/2026
Last edited: 21/08/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Abdulmohsen Alterki
Principal investigator

Kuwait City, Kuwait
Kuwait City
KW
Kuwait

Email	abdulmohsen.alterki@dasmaninstitute.org

Dr Salman Hussain
Scientific, Public

75 Laurier Ave E
Ottawa
K1N 6N5
Canada

Phone	+1 (0)613 562 5700
Email	salhussain@toh.ca

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Platelet-rich fibrin for postoperative recovery following pediatric adenotonsillectomy: a non-randomized clinical trial
Study objectives	To evaluate the effect of platelet-rich fibrin (PRF) on postoperative pain and recovery following pediatric tonsillectomy or adenotonsillectomy, and to compare two methods of PRF administration (injectable PRF and PRF membrane application) with standard surgical care without PRF.
Ethics approval(s)	Approved 05/07/2022, Kuwait Ethics Board Committee (Ministry of Health, Kuwait, Kuwait City, KW, Kuwait; +965 (0)24622228; -), ref: #19782022
Health condition(s) or problem(s) studied	Postoperative pain and functional recovery following adenotonsillectomy in children
Intervention	All participants underwent tonsillectomy, with or without adenoidectomy, under general anesthesia using a standardized cold-steel dissection technique. Tonsillectomy was performed by a single experienced surgeon, with care taken to minimize injury to the palatoglossus and palatopharyngeus muscles. Participants were allocated non-randomly to one of three parallel treatment groups: Control group: Participants underwent standard tonsillectomy or adenotonsillectomy alone and received no platelet-rich fibrin (PRF) treatment following tonsil removal. Injectable PRF group: Following tonsillectomy, autologous PRF was prepared from venous blood obtained from the participant and processed by centrifugation. The resulting liquid PRF was administered by injection into the tonsillar fossae bilaterally at the completion of tonsillectomy. PRF membrane group: Following tonsillectomy, autologous PRF was prepared from venous blood obtained from the participant and processed to produce a PRF membrane. The membrane was applied directly over each tonsillar fossa bilaterally. A single 4-0 Vicryl simple interrupted suture was used to approximate the posterior tonsillar pillar to the anterior tonsillar pillar to retain the membrane within the tonsillar fossa. PRF preparation: Approximately 10 ml of venous blood was collected into each of two tubes and centrifuged using the A-PRF liquid program at 1300 rpm for 14 minutes. Following centrifugation, approximately 4–5 ml of PRF product was separated from the red blood cell layer and used for injection or preparation/application of the membrane, according to treatment allocation. Postoperative care: Participants in all three groups received the same standard postoperative care and analgesic regimen.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Return to normal activity measured using postoperative day on which the child returned to normal activities or school at the presurgery level, measured at during postoperative follow-up until postoperative day 10 Cessation of analgesic medication measured using postoperative day on which postoperative analgesic medication was discontinued, measured at during postoperative follow-up until postoperative day 10 Postoperative pain intensity measured using the FACES pain scale at 2, 8, 14, and 24 hours after surgery and on postoperative days 3, 7, and 10
Key secondary outcome measure(s)	Postoperative hemorrhage measured using occurrence of any postoperative bleeding event requiring inpatient assessment or treatment during the postoperative follow-up period. Hemorrhage was classified as primary when occurring within 24 hours of surgery and secondary when occurring more than 24 hours after surgery at postoperative day 10 Adverse events measured using occurrence of adverse events potentially related to PRF administration during postoperative follow-up at postoperative day 10
Completion date	10/08/2026

Eligibility

Participant type(s)
Age group	Child
Lower age limit	6 Months
Upper age limit	17 Years
Sex	All
Target sample size at registration	206
Total final enrolment	262
Key inclusion criteria	1. Patients younger than 18 years of age 2. Tonsillar hypertrophy and/or adenoid hypertrophy meeting clinical criteria for tonsillectomy with or without adenoidectomy 3. Undergoing elective tonsillectomy or adenotonsillectomy 4. Written informed consent obtained from a parent or legal guardian
Key exclusion criteria	1. Active malignancy 2. Previous history of malignancy 3. Major cardiac comorbidities 4. Major respiratory comorbidities
Date of first enrolment	01/03/2023
Date of final enrolment	28/07/2026

Locations

Countries of recruitment

Kuwait

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

17/08/2026: Study's existence confirmed by the Ministry of Health, Kuwait.