Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 7:06 AM
Study NCT ID:
NCT07479602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to extubation after surgery', 'timeFrame': 'Up to 2 hours after surgery', 'description': 'Time to extubation at the end of surgery.'}, {'measure': 'Length of stay in PACU', 'timeFrame': 'Up to 24 hours after surgery', 'description': 'Length of stay in PACU after surgery.'}, {'measure': 'Incidence of adverse events during PACU stay', 'timeFrame': 'Up to 24 hours after surgery', 'description': 'Adverse events are defined as any events that required intervention during PACU stay, including laryngospasm, bronchospasm, airway obstruction, nausea and vomiting, desaturation (pulse oxygen saturation \\<90%), bradycardia (heart rate \\<60 beats per minute), bleeding, and others.'}, {'measure': 'Length of stay in hospital after surgery', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Length of stay in hospital after surgery.'}, {'measure': 'Incidence of complications within 30 days after surgery', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Postoperative complications are defined as new-onset condition that are deemed harmful and required therateutic intervention, i.e., class II or higher on the Clavien-Dindo classification.'}], 'primaryOutcomes': [{'measure': 'Area under curve of pain intensity within 48 hours after surgery', 'timeFrame': 'Up to 48 hours after surgery', 'description': 'Pain intensity will be assessed with the Face, Legs, Activity, Cry, Consolability scale (FLACC; scores range from 0 to 10, with higher scores indicating more severe pain intensity) at 10, 20, an 30 minutes after entering the post-anesthesia care unit (PACU), at 3 and 6 hours after surgery, and then twice daily (8:00-10:00 am, 6:00-8:00 pm) until 48 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Sleep quality during the first three nights after surgery', 'timeFrame': 'Up to three days after surgery', 'description': 'Sleep quality will be assessed by the guardians using the numeric rating scale (NRS; a 0-10 scale where 0=the best sleep and 10=the worst sleep) in the first three morning (8:00-10:00 am) after surgery.'}, {'measure': 'Cumulative consumption of analgesics within 48 hours', 'timeFrame': 'Up to 48 hours after surgery', 'description': 'Cumulative consumption of analgesics within 48 hours after surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adenotonsillectomy', 'Children', 'Intranasal administration', 'Dexmedetomidine', 'Esketamine', 'Postoperative pain'], 'conditions': ['Adenotonsillectomy', 'Children', 'Intranasal Administration', 'Dexmedetomidine', 'Esketamine', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '23668258', 'type': 'BACKGROUND', 'citation': 'Stanko D, Bergesio R, Davies K, Hegarty M, von Ungern-Sternberg BS. Postoperative pain, nausea and vomiting following adeno-tonsillectomy - a long-term follow-up. Paediatr Anaesth. 2013 Aug;23(8):690-6. doi: 10.1111/pan.12170. Epub 2013 May 13.'}, {'pmid': '17006062', 'type': 'BACKGROUND', 'citation': 'Brown KA, Laferriere A, Lakheeram I, Moss IR. Recurrent hypoxemia in children is associated with increased analgesic sensitivity to opiates. Anesthesiology. 2006 Oct;105(4):665-9. doi: 10.1097/00000542-200610000-00009.'}, {'pmid': '32666587', 'type': 'BACKGROUND', 'citation': 'Tan L, Carachi P, Anderson BJ. The time course of pain after tonsillectomy. Paediatr Anaesth. 2020 Sep;30(9):1051-1053. doi: 10.1111/pan.13970. Epub 2020 Aug 6. No abstract available.'}, {'pmid': '32440612', 'type': 'BACKGROUND', 'citation': 'Postier AC, Chambers C, Watson D, Schulz C, Friedrichsdorf SJ. A descriptive analysis of pediatric post-tonsillectomy pain and recovery outcomes over a 10-day recovery period from 2 randomized, controlled trials. Pain Rep. 2020 Mar 6;5(2):e819. doi: 10.1097/PR9.0000000000000819. eCollection 2020 Mar-Apr.'}, {'pmid': '30921630', 'type': 'BACKGROUND', 'citation': 'Levin M, Seligman NL, Hardy H, Mohajeri S, Maclean JA. Pediatric pre-tonsillectomy education programs: A systematic review. Int J Pediatr Otorhinolaryngol. 2019 Jul;122:6-11. doi: 10.1016/j.ijporl.2019.03.024. Epub 2019 Mar 22.'}, {'pmid': '37160822', 'type': 'BACKGROUND', 'citation': "Lima LACN, Otis A, Balram S, Giasson AB, Carnevale FA, Frigon C, Brown KA. Parents' perspective on recovery at home following adenotonsillectomy: a prospective single-centre qualitative analysis. Can J Anaesth. 2023 Jul;70(7):1202-1215. doi: 10.1007/s12630-023-02479-2. Epub 2023 May 9."}, {'pmid': '22023485', 'type': 'BACKGROUND', 'citation': 'Stewart DW, Ragg PG, Sheppard S, Chalkiadis GA. The severity and duration of postoperative pain and analgesia requirements in children after tonsillectomy, orchidopexy, or inguinal hernia repair. Paediatr Anaesth. 2012 Feb;22(2):136-43. doi: 10.1111/j.1460-9592.2011.03713.x. Epub 2011 Oct 25.'}, {'pmid': '24330523', 'type': 'BACKGROUND', 'citation': 'Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ. Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth. 2014 Mar;24(3):239-48. doi: 10.1111/pan.12327. Epub 2013 Dec 11.'}, {'pmid': '37407213', 'type': 'BACKGROUND', 'citation': 'Liu F, Kong F, Zhong L, Wang Y, Xia Z, Wu J. Preoperative Esketamine Alleviates Postoperative Pain after Endoscopic Plasma Adenotonsillectomy in Children. Clin Med Res. 2023 Jun;21(2):79-86. doi: 10.3121/cmr.2023.1818.'}, {'pmid': '30921525', 'type': 'BACKGROUND', 'citation': 'Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update)-Executive Summary. Otolaryngol Head Neck Surg. 2019 Feb;160(2):187-205. doi: 10.1177/0194599818807917.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative pain after adenoid and tonsil surgery is significant, with approximately 75% of pediatric patients experiencing severe postoperative pain. Currently, there is a lack of clinical strategies to safely and effectively manage postoperative pain in children undergoing adenoid and tonsil surgery. Dexmedetomidine and esketamine can achieve appropriate sedation levels and alleviate postoperative pain when used in children. Both drugs can be administered intranasally, and their pharmacological effects complement each other, reducing side effects. This study aims to investigate whether intranasal administration of dexmedetomidine-esketamine combination can improve postoperative analgesia in children undergoing adenoid and tonsil surgery.', 'detailedDescription': 'Adenoid and tonsil surgery is a common surgical intervention for obstructive sleep-disordered breathing and is one of the most frequently performed surgeries in pediatric patients. The operation lasts approximately 45 minutes but is associated with significant postoperative pain; about 75% of children experiencing severe postoperative pain, which can affect swallowing and may cause psychological distress in children. About 12-16% of children return to hospital after discharge due to pain or dehydration. Postoperative analgesia during the initial two days is often inadequate. Currently, clinicians have explored various strategies to effectively manage postoperative pain after adenoid and tonsil surgery in children, but the results are unreliable and have multiple side effects.\n\nDexmedetomidine is a highly selective α2 receptor agonist with anxiolytic, sedative, and analgesic effects, and has a minimal impact on respiration at low doses. When used as an adjuvant analgesic after surgery, it improves analgesia, reduces opioid consumption, and decreases opioid-related adverse events. Dexmdetomidine is also used in pediatric patients but may produce bradycardia and hypotension at routine doses. Ketamine is a non-competitive N-Methyl-D-aspartic acid (NMDA) receptor antagonist and has been used as an anesthetic and analgesic for decades. Esketamine is the S-enantiomer of ketamine and has an analgesic potent of approximately 2 times of that of ketamine. Esketamine is also used in children but may produce neuropsychiatric side effects.\n\nDexmedetomidine and esketamine can each be administered intranasally. When used in combination, the sympathomimetic activity of esketamine may counteract the bradycardic and hypotensive effects of dexmedetomidine, and the sedative effect of dexmedetomidine can mitigate the neuropstchiatric side effects of esketamine. Intranasal administration of dexmedetomidine-esketamine combination has been used for preoperative sedation in children and may improve postoperative analgesia after adenoid and tonsil surgery. However, the success rate and efficacy of intranasal dexmedetomidine-esketamine are difficult to guarantee in preschool children due to poor cooperation and intranasal secretions.\n\nThis randomized trial is designed to test the hypothesis that intranasal administration of dexmedetomidine-esketamine combination after anesthesia intubation may improve postoperative analgesia in children undergoing adenoid and tonsil surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 3-7 years old.\n* Scheduled to undergo adenoidectomy and/or tonsillectomy under general anesthesia.\n* Provides written informed consent by the guardian.\n\nExclusion Criteria:\n\n* Unsuitable for intranasal administration due to nasal diseases (such as rhinitis, nasal polyps, or any condition causing nasal congestion).\n* Clearly diagnosed cardiovascular and respiratory diseases.\n* Communication barriers due to delayed neurological development or visual or hearing impairments.\n* Traumatic brain injury or neurosurgery.\n* Abnormal liver and kidney function (biomarkers higher than twice of the upper normal limits).\n* Amercian Society of Anesthesiologists classification ≥ III.\n* Body mass index higher than the 95th percentile of the age- and sex-standardized references.\n* Allergic to dexmedetomidine and/or esketamine.\n* Any other conditions that are deemed unsuitable for study participation.'}, 'identificationModule': {'nctId': 'NCT07479602', 'briefTitle': 'Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Impact of Intranasal Dexmedetomidine-esketamine Administration on Postoperative Pain in Pediatric Patients Undergoing Adenotonsillectomy: a Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '2026-0115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Dexmedetomidine-esketamine combination will be administered intranasally after anesthesia induction.', 'interventionNames': ['Drug: Intranasal dexmedetomidine-esketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo (normal saline) will be administered intranasally after anesthesia induction.', 'interventionNames': ['Drug: Intranasal placebo (normal saline)']}], 'interventions': [{'name': 'Intranasal dexmedetomidine-esketamine', 'type': 'DRUG', 'description': 'A mixture of dexmedetomidine-esketamine combination will administered intranasally after anesthesia induction.', 'armGroupLabels': ['Intervention group']}, {'name': 'Intranasal placebo (normal saline)', 'type': 'DRUG', 'description': 'Placebo (normal saline) will administered intranasally after anesthesia induction.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Dong-Xin Wang, MD, PhD', 'role': 'CONTACT', 'email': 'wangdongxin@hotmail.com', 'phone': '01083572784'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Dong-Xin Wang, MD, PhD', 'role': 'CONTACT', 'email': 'wangdongxin@hotmail.com', 'phone': '01083572784'}, {'name': 'Ting Ding, MD', 'role': 'CONTACT', 'email': 'athena_d@sina.com'}], 'overallOfficials': [{'name': 'Dong-Xin Wang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician, Professor', 'investigatorFullName': 'Dong-Xin Wang', 'investigatorAffiliation': 'Peking University First Hospital'}}}}