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IRCT20110814007327N9 IRCT 2023-10-29 Tabriz University of Medical Sciences The comparison of anesthesia caused by lidocaine injection and/or lidocaine push with Diphenhydramine injection and/or Diphenhydramine push in the healing of head and face laceration. ED The comparison of anesthesia caused by lidocaine injection and lidocaine push with Diphenhydramine injection and Diphenhydramine push in the healing of head and face laceration 2023-10-22 anticipated 200 Complete https://irct.ir/trial/72290 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: After obtaining informed consent from patients, using Excel randomization software, patients are entered into 4 groups of 50 patients in parallel using a table of random numbers. Medicines and numbered syringes that only the researcher is aware of are used. In one group, lidocaine is injected around the wound. In one group, diphenhydramine is injected around the wound. In the third group, lidocaine is placed in the wound bed and margin, and in the fourth group, diphenhydramine is placed in the wound bed and margin. After five minutes have passed and anesthesia has taken effect, we will apply stitches. Pain intensity will be evaluated based on VAS. Data including age and sex, wound location, wound length and pain intensity will be collected based on VAS, Blinding description: In this study, the patient is unaware of the type and name of the drug, and the person who will analyze the data will also be unaware of which drug and how the drug is administered, but the doctor, researcher, and nurse are aware of the data. and the results will be informed. 3 head and/or face laceration. Intervention group: Traumatic patients with cerofacial lacerations with GCS=15. Patients who did not give the permission or have allergic reaction to Lidocaine or Diphenhydramin are excluded from study.Among the groups, the patients will be matched in terms of age and sex, so that after obtaining informed consent from the patients, using Excel randomization software, the patients will be entered into 4 groups of 50 people.Community Verified icon In one group Lidocaine is injected in the margin of wound. Dyphenhydramin is the other medicine which will be injected in second group. For the third group Lidocaine will be pushed around the margin of the wound and for the forth group pushing process will be done with Diphenhydramin. After 5 minutes we will start the suture of wound. Pain scaling will be done by VAS system.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no more information
public Samad Shams vahdati
Golgasht
Tabriz Iran (Islamic Republic of) ۵۱۵۶۸۳۴۵۶۳ +98 41 3335 2078 sshamsv@gmail.com Tabriz University of Medical Sciences scientific Samad Shams vahdati
Tabriz University of Medical Sciences, Golgasht Street,
Tabriz Iran (Islamic Republic of) ۵۱۵۶۸۳۴۵۶۳ +98 41 3335 2078 shams@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Traumatic patients who are in the age of 18 to 60 years with GCS=15 with head and/or face laceration 18 years 60 years Both the patients who did not give permission allergy Treatment - Drugs Intervention group: Traumatic patients with cerofacial lacerations with GCS=15. Patients who did not give the permission or have allergic reaction to Lidocaine or Diphenhydramin are excluded from study.Among the groups, the patients will be matched in terms of age and sex, so that after obtaining informed consent from the patients, using Excel randomization software, the patients will be entered into 4 groups of 50 people.Community Verified icon In one group Lidocaine is injected in the margin of wound. Dyphenhydramin is the other medicine which will be injected in second group. For the third group Lidocaine will be pushed around the margin of the wound and for the forth group pushing process will be done with Diphenhydramin. After 5 minutes we will start the suture of wound. Pain scaling will be done by VAS system. Pain. Timepoint: Before process, during the injection of anesthesia, At the time of stitching. Method of measurement: VAS scaling. Tabriz University of Medical Sciences Approved 2023-04-25 Ethics Committee in Tabriz University of Medical Sciences Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)