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Effect of local sucralfate and clindamycin on reduction of post tonsillectomy pain in 4-12 years children

Effect of local sucralfate and clindamycin on reduction of post tonsillectomy pain in 6-12 years children: a triple blinded randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201303209014N16
Enrollment
105
Registered
2013-04-21
Start date
2013-04-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sore throat. Pain in throat

Interventions

Intervention 1: Intervention 1: Oral irrigation with 10 ml of normal saline including clindamycin with 3 gr per 120 ml concentration for one min, immediately before and after surgery and then 3-time a
Treatment - Drugs
Placebo
Intervention 1: Oral irrigation with 10 ml of normal saline including clindamycin with 3 gr per 120 ml concentration for one min, immediately before and after surgery and then 3-time a day for three d
Intervention 2: Oral irrigation with 10 ml of normal saline including sucralfate with 3 gr per 120 ml concentration for one min, immediately before and after surgery and then 3-time a day for three da
Control: Oral irrigation with 10 ml of normal saline including cellulose (as plaocebo) with 3 gr per 120 ml concentration for one min, immediately before and after surgery and then 3-time a day for th

Sponsors

Vice chancellor for Research the Technology, Hamadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (a) patients who were undergone tonsillectomy with or without adenoidectomy; (b) age of 4-12 years of both genders. Exclusion criteria: (a) sensitivity to sucralfate and clindamycin or any of the macrolide antibiotics; (b) having chronic diseases such as congenital malformation, haemorrhagic disease, and Type I diabetes.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Measuring daily sore throat for five days giving 0-10 scores. Timepoint: During 5 days after surgery. Method of measurement: Faces Pain Scale Revised.

Secondary

MeasureTime frame
Nausea. Timepoint: During the first 5 days after surgery. Method of measurement: Questionnaire.;Vomiting. Timepoint: During the first 5 days after surgery. Method of measurement: Questionnaire.;Bleeding. Timepoint: During the first 5 days after surgery. Method of measurement: Questionnaire.;Number of times of using acetaminophen. Timepoint: During the first 5 days after surgery. Method of measurement: Questionnaire.;Number of times awaking at night. Timepoint: During the first 5 days after surgery. Method of measurement: Questionnaire.;Bad breath. Timepoint: During the first 5 days after surgery. Method of measurement: Questionnaire.;Otalgia. Timepoint: During the first 5 days after surgery. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Sara Pazira

Besat Hospital

S_pazira2009@yahoo.com+98 912 361 9347

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 7, 2026